South African surgeons were expected to perform a breakthrough life-changing operation on Monday on a severely scarred burn patient – using grafts that have been cloned from her own skin.
Little Isabella Kruger (fondly known as Pippi), who was burned on more than 80 percent of her face and body in an accident in December, and who turned three years old on Saturday, will become the first patient in the country to undergo the historic surgery.
New biotechnology that enables a patient’s own healthy skin cells to be cloned into skin grafts to cover their burns is only available from a specialised laboratory in the US. The procedure is seldom done outside the US because of the logistics involved.
But Isabella’s mother, Anice, found out about the technology from the internet and, late this afternoon, her daughter’s new cloned skin is expected to arrive with a courier in Johannesburg.
Genzyme, a global leader in cell therapy manufacturing, which grew the grafts from two small pieces of Isabella’s skin, had to book two tickets on the Delta Airline flight on Sunday – one for the courier and the other for the stainless steel box, containing 41 sheets of Isabella’s cloned skin, which was strapped into the seat next to him.
“The skin hangs vertically in the box and has to stay upright. Because it can’t be shaken around, it can’t go in the aircraft hold,” said Dr Alan Barrett, head of the medical department of Genzyme’s South African subsidiary company.
“The cloned skin looks like transparent plastic sheeting,” he said. “It is very thin and does not look like skin at all. The plastic surgeon will have to use blunt forceps so he doesn’t damage it.”
As the skin grafts have to be used within 24 hours of leaving the laboratory to prevent deterioration and to increase the chances of success, no time will be wasted in getting them to the operating theatre at Netcare’s Garden City Clinic, Johannesburg. There the surgical team will be waiting to perform the operation that will enable Isabella to come out of the isolation area of the burns unit and start a new life.
The plastic surgeon who is performing the operation, Dr Ridwan Mia, had to get an import permit from the Department of Health to bring in the grafts in terms of the Human Tissue Act, as well as an export permit when he sent two small skin biopsies from Isabella to Boston so that they could be cultured into grafts.
The airport clinic will collect the Genzyme courier, who has the import permit with him, ensuring that he gets through customs quickly.
Barrett, who will also go into the theatre for the unique operation, will sign for the grafts on behalf of Genzyme and they will be rushed to the clinic by Netcare’s organ transplant emergency service.
The two-hour operation will be the turning point for Isabella, who was burned at the family’s home in Lephalale in Limpopo, where her father Erwin, is a professional hunter.
Although her burns covered more than 80 percent of her body, she began to heal over the months, particularly on her face, although there is still some wound scarring – and 40 percent of her skin has since grown back.
But, she does not have enough healthy skin of her own to enable the plastic surgeon to do the necessary skin grafts to her face, chest, both arms, two burns on her legs, her sides and on a few other wounds.
The alternative was to use skin that had already healed, but Mia said that this posed enormous problems, “and we did not need to create new injuries”.
Then Isabella’s mother turned to the internet to research burn wounds and found the Genzyme website and its “Epicel” (cultured epidermal autografts) product, which can be grown to cover an entire body if need be.
A skin biopsy kit, containing an antiobiotic medium, was sent to the Garden City Clinic and Mia had to take two 2cm x 6cm size biopsies of healthy skin from Isabella’s groin which had been protected by the nappy she was wearing on the day of the fire.
Once these had arrived in the US, it took a week to isolate the cells from the biopsies and another two weeks to grow: to multiply in culture until there were enough cells to supply the number of grafts the plastic surgeon needed.
Epicel is manufactured with and contains residual amounts of mouse cells. The mouse cells are used as a structure, but as they do not contain DNA, cannot multiply. It is only Isabella’s cells that multiply.
Asked if she was excited about the operation, Isabella’s mother said: “If I was a balloon, I would probably have burst by now.”
For a long time after the tragic incident, Isabella’s prognosis was “very poor”, the plastic surgeon recalled.
She was swollen three times her normal size and had to have multiple blood transfusions.
And as she was on a ventilator for weeks, the once talkative toddler cannot speak and is only expected to begin talking again some six months after the operation. She was on a ventilator and had a tracheotomy for a total of 19 weeks.
“We took our lead from Isabella and as she improved, we moved to the next step. But she is a fighter and has come a long way. She defied all the odds,” Mia explained, adding that he has never seen such a young child survive with such severe burns.
It took almost two months to stabilise Isabella, which is considered an outstanding achievement, since the survival rate of such extensive burns in South Africa is less than 10 percent.
Her mother was unable to hold her for 12 weeks, because of her unstable medical condition and then because the pain was too severe.
It was 150 days before her family saw her smile.
After tonight’s operation, which will be filmed, Isabella will have to be immobilised for about a week to enable the grafts to take and develop a blood supply.
“We will put her in splints to stop her moving her elbows. We will keep her somewhat sedated so she is not too uncomfortable and is pain free,” Mia explained.
“We will open the first dressing in about a week, and then again two days later.”
All the dressings should be removed in two weeks. In the event that the grafting is not 100 percent successful, Isabella will still be able to access some of her cloned skin. Her cells are being preserved in a freezer in Boston and additional sheets of skin can be grown from it.
Isabella saw her baby brother, Arno, who will be one later this month, for the first time since the accident at her birthday party held at the hospital on Saturday.
She is expected to be in hospital for another three weeks, then she will be transferred to the Milpark Rehabilitation Centre for three to six months before going home.
Genzyme’s global medical doctor for the department which produces the skin grafts, Dr Sven Kili – an ex-South African – will be flying in from the US to oversee the operation.