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Dr. Filippo Milano, associate director of the cord blood program at Hutch, has received the $ 1 million grant allocated to the National Heart, Lung, and Blood Institute test.
For patients with critically ill leukemia, a transplant may be their best hope. However, Milan stated that, since HIV-positive blood cancer patients are considered to have active infections that put them at increased risk of complications, they have difficulty qualifying in many ways. centers for conventional bone marrow or blood stem cell grafts.
The pioneering Milano program on cord blood at Fred Hutch is used to finding options for blood cancer patients who can not find a suitable donor for a bone marrow or blood stem cell transplant. Cord blood, which contains immature blood cells that are less likely to attack the patient's own tissue, may be an alternative for patients with HIV-positive leukemia.
"We are not doing this test to cure HIV," said Milano. "We do it to cure patients with hematologic malignancies and concomitant HIV infection."
The mutation seals a molecular gateway against HIV
Yet this trial also offers a tantalizing bonus: the researchers plan to offer these patients cord blood from about one in 100 donors who are naturally resistant to HIV. Indeed, these patients with leukemia will emerge with the immune system of a person who would not be susceptible to the virus. The hope is that this HIV-resistant immune system will eventually eliminate the last pockets of HIV, which can purr without continued treatment with antiretrovirals.
To date, only one person in the world known to have been cured of HIV has been recognized: Timothy Ray Brown, born in Seattle. In 2007, while living in Germany, Brown – whose HIV was controlled by antivirals – had received the first of two bone marrow transplants for leukemia. His doctor has used donor cells carrying an HIV resistance mutation in a gene that affects a protein called CCR5.
In most people, CCR5 works as a kind of molecular gate. HIV can open this door and enter an immune cell. But 0.8% of the world's population inherits both their mother and father from a genetic mutation that effectively seals this door, and these lucky few are naturally resistant to HIV. It is such donors that Brown received his new immune system and, eleven years later, he still has no trace of HIV and his leukemia remains in remission. To date, no other patient who has benefited from such a transplant has remained seronegative for HIV. The Milano trial will attempt to replicate Brown's experience using cord blood.
An experimental product based on cord blood is the key to a trial
In this trial, patients will receive a single unit of cord blood, which contains a very small number of immature blood cells. However, each patient will also receive a dose of a yet experimental product, dilanubicel, from Nohla Therapeutics. The Seattle Society was created by Dr. Colleen Delaney, Fred Hutch Researcher, Madeline Dabney Adams Research Chair and Hutch Cord Program Director.
Derived from cord blood cells that are multiplied in the laboratory, the investigational drug is administered with the transplant cells to protect the patient from infection until grafted cord blood cells have time to complete. install as a functional immune system.
"The number of stem cells in the cord blood is very limited, especially in adults because they come from a baby's umbilical cord," said Milano. "The Colleen product allows the cord blood to be grafted and protects the patient."
By including the drug Nohla in the test, cells from only one umbilical cord are needed instead of the two cells usually needed for cord blood transplants. As a result, it is necessary to find only one donor carrying the mutation, which increases the chances of meeting the needs of a patient seeking an HIV-blocking mutation in the transplant. Milano calculates that there are about 6,500 units of this type stored in cord blood banks around the world. The hope is to find several dozen units, stored at the Cleveland Cord Blood Center, that would suit this test perfectly.
The plan calls for patients to be treated at one of five US cancer centers that also have expertise in HIV treatment.
"We will have world-class cancer doctors who will work with world-class HIV experts," said Milano.
Participating hospitals working with Hutch include UW Medicine and Seattle Children's Hospital; University / University Hospitals Case Western Cleveland Medical Center; Children's Research Institute / National Medical Center for Children, Washington, D.C .; The Memorial Sloan Kettering Cancer Center in New York; and the University of California, San Francisco Medical Center.
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