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Star surgeon Paolo Macchiarini was the first in the world

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to surgically implant a plastic trachea in a human being.

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The ground-breaking surgery

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gave the man back his trachea and his life.

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He promoted a future with more organs made of plastic,

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such as hearts and lungs.

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..a few years away from this all happening,

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all organs being built in a lab.

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But privately, Macchiarini started to discover faults

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with his tracheas...

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So I think that we need to redo everything again.

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..and patients were beginning to die.

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I didn't do anything wrong.

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I...just did my job.

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But despite the faults,

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Macchiarini made plans for new operations with plastic organs.

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If he succeeded, he would be revolutionising the medical world.

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But if not, it would be one of the most spectacular falls

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in the history of international medicine.

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You are crazy.

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Does a human life have a price?

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I didn't do anything wrong.

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I...just did my job.

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By spring 2012,

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the atmosphere was tense in Macchiarini's lab

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at the prestigious Karolinska Institute

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in Stockholm, Sweden, home of the Nobel Prize.

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It was here, amongst other places,

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that Macchiarini tried to solve the problems

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that had recently been discovered with the plastic tracheas.

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Paolo was now fighting to succeed.

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In his view, it wasn't the plastic trachea

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which had caused the death of the patient,

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but the patient had simply been too ill.

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For clearer results,

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he wanted to try his method on stronger, healthier subjects.

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People who were not fatally ill.

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Despite the method having been tested so little,

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Paolo had managed to achieve something nearly impossible.

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He was granted permission to start a clinical study on humans.

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The first trials would take place in Russia.

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For some time, they had searched for the right volunteers here.

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Many candidates pitched their case for treatment

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and the Karolinska Institute in Stockholm

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had assisted in making the final selection.

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Julia Tuulik had been chosen to be the first experimental subject.

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She was asked to record a video,

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explaining why she wanted the operation.

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Both Julia and Paolo were now heading towards the hospital

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in Southern Russia.

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At this point, Paolo's international reputation was at its peak.

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A German TV crew was recording a documentary about him

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and his operation on Julia.

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This footage is taken from their unedited material.

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The recordings give a unique insight into Paolo's medical experiments.

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The more I saw, the more questions I had for Paolo.

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But I would have to wait a long time before I could put them to him,

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and only after I had looked through all his past experiments.

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It all began four years earlier for Julia.

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She and her husband at the time were driving

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when a truck crashed into them.

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Miraculously, they survived.

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Julia was pregnant

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and she would put up with just about anything to protect her child.

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In order to speak,

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Julia had to cover the hole in her throat with her hands.

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You can live a long life with a tracheostomy.

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But the hole in her throat bothered her...

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..and she wanted to be her old self again.

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During the last leg of the journey,

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Julia was interviewed by the interpreter for the German crew.

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-Come in.

-Come in.

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This is the German physician Philipp Jungebluth -

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Macchiarini's right-hand man.

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It was he who prepared the plastic tracheas.

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First, bone marrow was extracted from Julia's hipbone.

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The cells were mixed into liquid,

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which was then poured over Julia's new plastic trachea.

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The trachea was left to rotate for several days.

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A number of tracheas were prepared as extras.

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LAUGHTER

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With one day to go before the operation,

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Paolo arrived.

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Let's go.

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-Here you go.

-OK.

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Do you want something? Cup of tea, coffee, water?

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-No, no.

-No?

-I just want to talk to...

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-To...?

-Igor.

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Igor, OK. Please take a seat.

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Igor Polyakov was going to operate together with Macchiarini.

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Nice to meet you.

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Let's go, then.

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This was beginning to sound worrying.

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It seemed like all the plastic tracheas

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had something wrong with them.

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And yet, no-one seemed to consider cancelling the operation.

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Instead, everything continued as planned.

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Now Julia was going to find out how the plastic trachea works.

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David Green, the president of the American company

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which made the bioreactor, would explain this to Julia.

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-Hello.

-Hello.

-Is it OK to come in?

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-Yes.

-Yes?

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-I'm David.

-Julia.

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David Green. Nice to meet you. Can I sit here?

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So, Olga and Victor told me that you would like to see

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the trachea scaffold and the bioreactor.

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So...

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So, these are sterile.

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But this is exactly the same as what will go into you tomorrow.

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So when the doctors came two months ago...

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You can touch it. You can feel it.

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When the doctors came two months ago,

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they took the scans, the CAT scans of your neck...

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..and this is made to the exact dimensions.

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But this has no cells.

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Your trachea has cells and blood vessels.

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So, when this has the cells on it, it will look like normal tissue.

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It is plastic.

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It is the same plastic that this bottle is made from.

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It says on the bottom here, for recycling, it says PET.

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This is the same plastic.

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But this is food grade.

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This is medical grade.

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So this is much, much purer.

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This is just...

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..for industrial use.

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So we know this material is very safe.

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And this, you cannot get, naturally.

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So we have to make it. But I can show you.

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So, this is Mr Andemariam Beyene.

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Did you hear about this?

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He received his trachea one year ago.

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Very similar.

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Very similar to this.

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We all went to Iceland with all the surgeons

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to make a celebration,

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like, a one-year birthday party for him.

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One week earlier, David Green had been to Iceland,

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where he took the photo he showed her.

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In the photo was Andemariam Beyene,

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Paolo's first plastic trachea patient.

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Green and Macchiarini's team had travelled there

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to celebrate the one-year anniversary of the operation.

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It is, of course, a big moment for both us,

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the team here in Iceland,

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and, of course, the team in Karolinska...

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They had held a press conference about the operation.

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Back then, nobody knew that we would be here,

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one year later, in Iceland, to celebrate this anniversary.

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So it's a huge clinical milestone.

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When I saw him the first time,

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he asked me, "What you want to do with me?"

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I explained to him.

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His first reaction was just to look at me

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and say, "Well, you are crazy."

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And he said...

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Well, I said, "Yes, I am.

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"But this is the only chance you have right now."

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But at this point, one week before Green's visit to Julia,

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Macchiarini knew there was also a fault with Andemariam's trachea.

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He had made this discovery earlier that spring.

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But this seriousness of the situation

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was covered up during the press conference.

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Was there a wish to portray the operation

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as a greater success than it really was?

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In fact, Andemariam had not been very well at all.

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His wife Merhawit remembers that it seemed to have been a success

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right after Andemariam had received his new trachea.

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But slowly it had become clear that all wasn't as it should be.

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These events have been so painful for the family

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that Merhawit doesn't want herself or the children

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to be shown in this documentary.

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COUGHING

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Merhawit also remembers the one-year anniversary

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and how the operation was portrayed as a success.

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In reality, shortly before the press conference,

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Andemariam had been forced to fly to Sweden for treatment.

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The examination filmed from the Karolinska Hospital

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shows inflammation

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and an increasingly problematic trachea.

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He'd had trouble keeping his airways open,

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and he had coughed up blood and mucus.

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They had to insert a steel net in order for him to breathe.

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Paolo was the responsible consultant at Karolinska.

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Surely he couldn't have missed this?

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What we saw in Karolinska is that, um...

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..after so many hours, the scaffold are very, very...soft,

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so they need to be dry before implanting,

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because otherwise they will collapse completely.

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What did Paolo's team here in Krasnodar know about the problems?

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Could they have told Julia about the risks?

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You can touch it...

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Did Green lead Julia to believe that everything was tried and tested?

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So we know this material is very safe.

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Could he have focused more on the risks?

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So this can turn like this, to turn it around,

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and this is mounted in here,

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and then the stem cells are poured in here,

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and this rotates very slowly.

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So they are in the bioreactor for two days.

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It is completely sterile and then it's done.

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And then tomorrow, they will put this into you,

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but after it goes in, it still has no blood supply,

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so it takes about seven days

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for your body to grow new blood vessels through the scaffold,

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and then it will be your new trachea.

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It will be just like this -

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you'll be sitting in bed, lying in bed.

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You are in very good hands for the next seven days.

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Paolo is the best surgeon in the world.

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There is no-one better who can do this surgery for you.

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-I know.

-You know.

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You're right.

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Very nice meeting you, Julia.

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-Bye-bye.

-Bye. Thank you.

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You're welcome.

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This is the final brainstorming before the transplantation.

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Julia, tomorrow, will be the first patient

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entering a clinical trial.

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We need to go through every single step.

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When I watched this, I wonder why it all seemed so rushed.

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This distance should be covered.

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We need to give credit to Professor Porhanov.

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The pressure that he and I have

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from different ministry authorities is extremely high.

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They want that this will be a success.

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And I am confident that we will do the best.

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Was it the pressure from ministers and financiers

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that made Paolo push on?

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If we could do the transplantation

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by just doing...through a cervical incision only,

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this would be a major achievement.

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I mean, she will be going, making interviews

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and so forth and so forth, and if...

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SPEECH FADES

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Shortly before the operation, Paolo and Julia finally met.

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-You look beautiful.

-Thank you.

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Even if Julia had been informed that this was an experiment

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and perhaps also signed a document,

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she doesn't seem to have understood the risks she was about to take.

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Not even her Russian doctor, Polyakov,

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actually seemed to have been informed

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of the setbacks Paolo's method had had.

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We have to...we have to know their wishes.

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OK, so this is the zone...forbidden, OK? OK.

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Any scars, but...out of this zone.

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The time had finally come.

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Paolo would have the opportunity to implant the plastic trachea

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in a patient who quite possibly had a long life ahead of her.

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Suction.

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Stop ventilation.

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You just keep it...

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Good, good.

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Congratulations to everybody. Really.

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It's also plastic, so it's really tricky.

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Just a few days later, a press conference was called.

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APPLAUSE

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Julia? Julia...

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This is Julia.

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Eto Julia.

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When I met Julia, she was not able to play with her child.

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It was a very emotional moment for me.

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RUSSIAN INTERPRETER SPEAKS

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And I immediately said, "This is the right patient."

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And I still do not believe that a few days ago,

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she couldn't breathe and talk normally.

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So, um, she's a little bit afraid of you,

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so please be very sweet.

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INTERPRETER SPEAKS

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She can... She can...

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She can answer all the questions that you would like.

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APPLAUSE

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APPLAUSE

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It seemed like an all-round success.

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Julia was seemingly on the road to complete recovery

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and Macchiarini could show off

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a ground-breaking plastic trachea transplantation

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to the media, ministers and financiers.

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Now, he could continue doing research and performing operations.

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Igor?

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-Cheers.

-Cheers.

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LAUGHTER

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Borscht, maybe?

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Another patient had been operated on almost immediately after Julia.

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His name was Alexander Zozulya.

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The operation was viewed on TV in an adjacent room.

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Here was American paediatric surgeon Mark Holterman.

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Together with Paolo,

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he would soon implant a plastic trachea in a child.

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Parallel with the trials in Russia,

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Paolo continued to implant plastic tracheas

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in patients who were seriously ill.

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The operation took place in the US on two-year-old Hannah Warren,

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born without a windpipe.

0:37:230:37:25

-It's OK.

-Don't worry about it.

0:37:250:37:28

And then there was one more patient-in-waiting.

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22-year-old Yesim Cetir from Turkey.

0:37:370:37:41

Yesim was not part of the Russian trials

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but was operated on at Karolinska Hospital in Stockholm,

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where Macchiarini's plastic trachea transplants had first begun.

0:37:510:37:55

Yesim's operation to replace her own damaged trachea failed.

0:38:000:38:03

The plastic trachea wouldn't take hold

0:38:050:38:07

and it lost its shape.

0:38:070:38:08

It had to be cleaned every four hours

0:38:100:38:12

to prevent her from suffocating.

0:38:120:38:14

After a year, Yesim had a new plastic trachea implanted,

0:38:160:38:20

but matters didn't improve.

0:38:200:38:22

In the end, Yesim stayed in hospital for over three years.

0:38:240:38:28

Hannah Warren also remained in intensive care.

0:38:350:38:38

She died three months after having received her plastic trachea.

0:38:430:38:47

The condition of Andemariam,

0:38:540:38:56

Macchiarini's first plastic trachea patient,

0:38:560:38:59

also worsened.

0:38:590:39:00

He felt that there was something wrong with his trachea,

0:39:030:39:05

and he tried to reach Macchiarini.

0:39:050:39:07

Not only the patients felt that Paolo wasn't there

0:39:560:39:58

when they needed him.

0:39:580:40:00

While Macchiarini travelled across the world,

0:40:040:40:07

the hospital staff back in Stockholm were left to deal with the patients

0:40:070:40:11

and their severe complications.

0:40:110:40:13

One of the doctors dealing with Paolo's patient was Thomas Fux.

0:40:150:40:19

Now, even the management started to have issues

0:40:530:40:56

with Macchiarini's methods.

0:40:560:40:58

In October 2013,

0:40:590:41:01

his transplantations were stopped at Karolinska Hospital.

0:41:010:41:04

But since Paolo's experimental work had been suspended,

0:41:070:41:10

his patients were left without specialist help.

0:41:100:41:13

Thomas Fux tried to fill the void.

0:41:140:41:17

He and his colleagues would now make a very surprising discovery.

0:41:190:41:23

Their suspicions about Paolo's reports

0:42:140:42:17

were about to be confirmed.

0:42:170:42:18

Andemariam returned one last time to Karolinska.

0:42:270:42:30

SHE CRIES

0:43:120:43:14

Andemariam Teklesenbet Beyene passed away in January 2014.

0:43:340:43:39

From the autopsy report,

0:43:410:43:43

the doctors now discovered the truth about his plastic trachea.

0:43:430:43:47

There were no signs that a new organ had been created -

0:43:490:43:53

only inflammation and dead tissue.

0:43:530:43:55

The plastic trachea was so loose that it could simply be lifted out.

0:43:570:44:01

It was far worse than the doctors had ever imagined.

0:44:040:44:07

They decided to compare the test results

0:44:080:44:11

of the plastic trachea patients in Sweden

0:44:110:44:14

to the way they had been described in Macchiarini's scientific reports.

0:44:140:44:19

They soon discovered a pattern.

0:44:200:44:22

There is information about certain problems in Macchiarini's work,

0:45:330:45:37

but nothing about the many times

0:45:370:45:39

Andemariam needed emergency treatment

0:45:390:45:42

and nothing about a chronically infected trachea

0:45:420:45:45

that eventually came loose,

0:45:450:45:48

or about the fact that Yesim had endured

0:45:480:45:51

more than 7,000 examinations and operations.

0:45:510:45:54

The doctors now alerted their superiors at the Institute

0:45:560:45:59

and the University Hospital.

0:45:590:46:01

Macchiarini's operations had been stopped in Sweden.

0:46:210:46:24

But Fux and his colleagues were worried that the flawed procedures

0:46:260:46:30

would still take place in other countries,

0:46:300:46:32

placing more lives at risk.

0:46:320:46:35

The doctors asked their superiors

0:46:380:46:40

to alert the medical world to what had really been going on.

0:46:400:46:43

Otherwise, other patients risked receiving Paolo's plastic trachea.

0:46:460:46:50

Others like Julia.

0:46:520:46:54

She was one of the patients meant to prove that the method worked.

0:46:580:47:02

How was her recovery after the operation?

0:47:030:47:06

This is something Macchiarini has said very little about publicly.

0:47:080:47:12

A few days ago, she couldn't breathe and talk normally.

0:47:130:47:17

APPLAUSE

0:47:170:47:20

This is the last footage I saw from the German recordings.

0:48:570:49:02

Watching this footage

0:49:020:49:04

had generated many questions I wanted to put to Paolo.

0:49:040:49:06

But first, I had to follow this story to the end.

0:49:080:49:11

I suspected that I would only get one more chance to interview Paolo.

0:49:130:49:17

When he and his team flew off to the next operation,

0:49:220:49:25

everything went back to normal...

0:49:250:49:27

..for everybody except for Julia.

0:49:300:49:34

Julia spent as much time as she could with her son,

0:49:380:49:42

but everything wasn't as it should be.

0:49:420:49:44

Julia had to be rushed back to the hospital in Krasnodar

0:50:270:50:30

to get help.

0:50:300:50:31

Her surgeon told me what had gone wrong.

0:50:360:50:38

First, the problem with the scaffold.

0:50:390:50:42

It collapsed.

0:50:420:50:44

It collapsed over time.

0:50:460:50:48

Polyakov had to insert a steel net into Julia's trachea

0:51:090:51:13

to prevent her from suffocating.

0:51:130:51:15

She remained in Krasnodar for months.

0:51:180:51:20

Without the plastic trachea,

0:51:240:51:26

Julia might have had a normal lifespan.

0:51:260:51:29

But the situation continued to be life-threatening.

0:51:310:51:34

Julia was able to return home.

0:51:560:51:58

But she was constantly suffering from infections.

0:51:590:52:02

Macchiarini's team had no other solution

0:52:090:52:12

than to insert a new plastic trachea.

0:52:120:52:15

But it didn't help.

0:52:220:52:23

It was here in her apartment that Julia spent her last days.

0:53:000:53:04

Julia's sister-in-law remembers her final days.

0:53:190:53:22

Julia Tuulik died at home alone in September 2014.

0:54:020:54:08

It had been seven months

0:54:250:54:26

since the doctors of Karolinska had warned their superiors

0:54:260:54:30

that Paolo's methods could result in the death of his patients.

0:54:300:54:34

One might think that such serious warning signs

0:54:360:54:39

would have made the management at Karolinska act a long time ago.

0:54:390:54:43

But despite several meetings, e-mails and conversations,

0:54:440:54:49

they did not share these warning signs.

0:54:490:54:51

And in Russia,

0:54:530:54:54

Paolo's trials on almost completely healthy patients continued

0:54:540:54:59

with Dmitri Onogda.

0:54:590:55:01

The doctors got more and more frustrated

0:55:060:55:09

with their superiors' lack of reaction.

0:55:090:55:12

Therefore they decided to take drastic action.

0:55:120:55:15

They documented all the faults they could find

0:55:150:55:18

in a 400-page-long report

0:55:180:55:21

and filed it with the Vice Chancellor

0:55:210:55:23

at the Karolinska Institute.

0:55:230:55:25

Although lives were at stake,

0:55:530:55:55

it wasn't until nine months after the doctors' warning

0:55:550:55:59

that the Vice Chancellor of the Karolinska Institute

0:55:590:56:02

commissioned an independent enquiry.

0:56:020:56:05

What was going on in Karolinska Hospital

0:56:350:56:38

and the Karolinska Institute?

0:56:380:56:40

Were they trying to silence the doctors?

0:56:410:56:43

Did they not want to investigate Macchiarini's operations

0:56:440:56:47

and his research?

0:56:470:56:48

I had seen patient after patient die,

0:56:560:56:59

but according to Macchiarini,

0:56:590:57:01

the tracheas had nothing to do with the deaths.

0:57:010:57:04

He had presented all the facts correctly

0:57:040:57:07

and always been there for his patients,

0:57:070:57:10

but was this really the case?

0:57:100:57:12

In part three, Paolo will get to answer all of my questions.

0:57:120:57:17

Perhaps there's something I have missed.

0:57:170:57:20

Your profession is...?

0:57:210:57:23

Because she had so much...

0:57:240:57:26

Answer my question. Your profession is...?

0:57:260:57:28

-How do you mean?

-What are you doing as a job?

0:57:300:57:32

You have to explain what you mean.

0:57:340:57:36

You are... You are a producer, a TV producer, right?

0:57:360:57:40

How can you understand, possibly understand,

0:57:400:57:42

all the details of a medical evaluation?

0:57:420:57:45

-Now, I...

-You know all the details of a medical evaluation?

0:57:450:57:48

No, of course not.

0:57:480:57:50

But I've read all the documents with the investigation...

0:57:500:57:53

This is totally wrong, totally wrong.

0:57:530:57:57

You should revise your English.

0:57:570:57:58

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