It explained the alternative to a foreign cell transplant, but only in a few lines. The doctor, Christoph Klein, emphasizes that he himself had explained the alternative treatment presented in the written consent form - the transplantation of donor stem cells - to the parents of his patients before they agreed to gene therapy. Mahmoud's parents opted for the new gene therapy. In November , the study began.
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Mahmoud was five years old. Other parents were also convinced by the prospect of the new gene therapy. At the hospital in Minden, a doctor gave her the good and bad news. The good: Tom's bone marrow was okay. The bad: The doctor did not know exactly what was causing the illness. But we're still investigating. Don't Google it just yet Svenja read that her boy had perhaps just a few more years to live. But the professor from Bremen told them about the study in Hannover. Gene therapy is perhaps the greatest medical promise in history: Diseases can be remedied right where they began, in the genes of patients.
Past the symptoms, directly to the root causes. Gene therapy is a promise of salvation. For patients like Mahmoud, whose diseases are extremely rare, this is particularly true. Rare diseases are poorly understood - for about 7, of them, there are only drugs. In Germany alone, 3, children die every year from rare diseases.
Doctors are often unable to help because there are so few patients to learn from.
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And research is expensive, especially for those few people. But the history of gene therapy is also a history of risk. It's impossible to remove its association with the name of Jesse Gelsinger, an American who died in just four days after undergoing gene therapy. The University of Pennsylvania had broken clinical research rules in treating the year-old, who was not particularly sick compared with other patients suffering from the same illness as he. Gelsinger likely could have lived using a strict diet and good medicine. As it turned out, he wasn't just killed by his illness, but by the gene therapy treatment itself.
Since that first death it's been clear: Gene therapy doesn't just offer hope. On November 10, , Mahmoud was treated in Hannover, in this foreign country where late autumn is already frigid. But the doctors were friendly, and they were the world's best. The doctors in Hannover planned to treat a total of 15 children. The therapy was developed by Christoph Klein.
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At turn of the millennium, Klein was in his thirties and in the midst of an exceptionally brilliant career. He wondered whether he should become a musician or physician.
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Today he is a doctor, but he likes to emphasize that he's also an organist. Professionally qualified to play church music, Klein works as an organist and choirmaster part-time. As a youth he was an altar boy. He studied medicine in Ulm alongside psychology and philosophy, and also studied at Harvard Medical School, home to some of the best physicians in the world.
Klein specialized in pediatric oncology, the treatment of children with cancer. His colleague in a neighboring laboratory worked with mice. If he switched a gene off, the mice would become sick. Klein wondered: Could that work the other way around? If you could change a mutated gene, could you make a patient healthy? The rare congenital immunodeficiency usually leads to death in childhood within months or a few years. Fischer fought SCID successfully with gene therapy. It was a medical breakthrough that Klein, who was studying under Fischer and teaching at Harvard, was able to witness firsthand.
Colleagues from that era remember him as an excellent scientist who was quickly able to assemble a team. Doctors who worked at that time or later also describe a man whose identities as physician and scientist were not quite balanced: He was an ambitious researcher, but not always a doctor committed to his patients. In , Klein was promoted to director of the children's hospital in Hannover. It had only taken him about eight years. In the meantime, he had won five major awards for physicians.
Klein was intensely concerned with gene therapy, that idea with the mice and the idea that brought his old supervisor so much attention.
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Instead of transplanting stem cells from other human patients, he believed patients could be re-injected with their own stem cells after those had been removed and stripped of their altered genes. The group was funded by the Deutsche Forschungsgemeinschaft, one of the largest independent research funding organizations in Germany. It was an exciting time for scientists who dealt with genetic engineering. In the nineties, researchers around the world began to develop gene therapies for children suffering from immunodeficiency disorders. Apart from Alain Fischer's work in Paris, there was, for example, a study in London, another in Milan, and that of Klein's team in Hannover.
Given that gene therapy was still pioneering work, each step was difficult and results were uncertain.
And as Klein was drawing up the plans for his study, researchers knew significantly less about gene therapy than they do today. In gene therapy, individual genes are not easily moved back and forth.
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In order to move the improved Wiskott-Aldrich gene back into the genome of a patient, it must first be packed up, like a passenger put back into a taxi. Vectors must penetrate into the genome and then insert new genetic information that won't cause disease. These vectors are a complex invention, and they have improved over time, as new generations of vectors replace the old ones.
When he began his study, Klein was working with a very early generation. Gene therapy can be a long and trying process for the doctors who perform it.
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But there are also few types of medical work that can lead to so much glory if successful. Klein knew that well. Klein found several children who met the criteria of his study, and for him, this was a chance to cure a previously incurable disease. But for the kids, what was it? Klein remembers the time just before the study began. On July 29, , he submitted his study proposal to the ethics commission in Hannover.
Klein only needed to cross the hospital grounds to turn it in. The ethics committee's ultimate task is to protect patients. The protocol, trial plan and patient information all must be scientifically accurate, and only then should the committee approve a study. However, the committee still only examines a proposed study on paper.
When the committee received Klein's proposal, it had additional questions, so it wasn't until February 15, , that all of the study documents were finally ready to be examined. Klein was lucky to have turned his documents in when he did in , even though they were incomplete.