Bone marrow transplantation can be life-saving for patients suffering from certain diseases. Types of cancerFinding a suitable medication for blood disorders and other illnesses can take months or years – but for many patients, it can take months or years to find a suitable medication.
Each year, approximately 18,000 people in the U.S. are diagnosed with potentially fatal diseases that can be successfully treated. donated bone marrow,
To increase the chances of these patients receiving lifesaving treatment, bioengineering company Osium Health has created a program that provides deep-frozen bone marrow from deceased organ donors.
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Earlier this year, after an unsuccessful four-month search for a matching donor, a 68-year-old Michigan woman became the first patient to receive a bone marrow transplant from an unrelated organ donor. Blood cancer treatment,
Each year, approximately 18,000 people in the U.S. are diagnosed with potentially fatal diseases that could be successfully treated with donated bone marrow. (iStock)
The patient, who suffered from acute myeloid leukemia, received the transplant at Henry Ford Health. Detroit, MichiganAccording to doctors, she is now “recovering rapidly.”
“We were concerned about it because there was no precedent for using bone marrow from a cadaver,” Munir Abidi, MD, a hematologist at Henry Ford Health who led the clinical trials for Osium’s bone marrow product, told Fox News Digital during a phone conversation.
“So there was a little bit of apprehension and anxiety, but we were pleasantly surprised and delighted when she fully recovered her (stem cell) count, which was very similar to the expected time period for a normal, healthy donor.”
Bone marrow obstructions
According to Kevin Caldwell, CEO of Osium Health, bone marrow transplant is the ultimate treatment for blood cancer patients.
In the stream health care systemA blood cancer patient who needs a bone marrow transplant has to find a healthy volunteer who is a good fit for him.
“We were concerned about this because there was no prior precedent for using bone marrow obtained from a cadaver.”
“Unlike other organs, which you can transplant from one person to another, bone marrow has to be a very close match genetically,” Caldwell said during an interview with Fox News Digital.
He said that this process is not easy.
“The donor must be ready, willing and able to provide bone marrow for a complete stranger, have a hole drilled in his hip, have his bone marrow extracted or his stem cells harvested — take several days off from work and make a meaningful sacrifice to benefit someone he’s never met,” Caldwell said.
Bioengineering company Osium Health has created a new program that provides deep-frozen bone marrow from deceased organ donors. (Osium Health)
There is also the challenge of time in this.
“It can take months to find a person who is healthy enough and willing to donate, and Genetic Matching — and those are months that blood cancer patients often don’t have,” Caldwell said.
He said about 55% of blood cancer patients receive a successful transplant. The remaining 45% do not receive a transplant, and most of them do not survive.
Another widespread issue, according to Abidi, is that it is difficult for minorities, particularly African-Americans, to find perfectly suitable donors.
“The problem got worse during COVID,” he told Fox News Digital.
Fulfilment of the requirement
To address these issues, Osium Health has developed a bank of bone marrow that is obtained from organ donors.
“We have built a network of 27 organ procurement organizations across the United States that manage organ donation, obtain consent and perform retrieval,” Caldwell said.
Osium has launched a clinical trial – called PRESERVE I – that provides bone marrow to acute leukemia patients who require allogeneic (genetically identical) transplants. (Osium Health)
“We’ve trained them on how to retrieve the bone marrow, and then we’ve built the facility where we process and manufacture the doses for the patients, and we cryopreserve it on site.”
The goal is to have the bone marrow retrieved and donated like other organs — such as the heart, liver, lungs, kidneys, corneas and skin — which has been done for decades, Caldwell said.
“Before Osium, bone marrow obtained from these donors – life saving stem cells “The proteins that were present in the vertebral bodies of these donors were not being used,” Caldwell said.
“Despite the fact that these people had consented to organ donation, it would be rejected.”
Osium has launched Clinical Trials – called Preserve I – which provides bone marrow to acute leukemia patients who need allogeneic (genetically identical) transplants.
The first patient to be enrolled in the trial, a Michigan woman, will receive a transplant in May 2024 through Osium’s HOPE program.
The ultimate goal, Osium’s CEO said, is to “dramatically expand” the reservoir of bone marrow stem cells obtained from deceased organ donors to help fight cancer. (iStock)
“Today, she is alive and well and recovering very well from her blood cancer, because we had a bone marrow unit that was a good fit for her and could save her life,” Caldwell said.
“This case demonstrates the importance of this new option for patients in urgent need.”
Benefits of cryopreserved bone marrow
Caldwell said there are several advantages to using bone marrow from deceased donors — the biggest advantage being that more of the organ can be used.
“Our donors no longer need bone marrow, so we are able to obtain more bone marrow than we could ethically obtain from a living person who still needs bone marrow to survive,” he said.
According to Caldwell, on average, they are able to get two to five times more cells from an organ donor than from a living person.
“Our donors no longer need bone marrow, so we are able to obtain much more bone marrow than we could ethically take from a living person.”
“This could mean we could do multiple transplants from one donor and save many lives.”
In other cases, they may be able to provide larger doses of stem cells, leading to improved Patient Outcomes,
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“For the first time, the doctor has a choice of what dose he wants to give his patient — just like when he decides on a dosage. Prescribing medicationCaldwell told Fox News Digital.
Immediate availability is also a big advantage, Abidi said.
“The product is already available and collected, and we know exactly where it is stored,” he said.
Ossium built the facility where they process and manufacture the bone marrow doses for patients, and cryopreserve them there.” (Osium Health)
“When we contact a healthy donor, it can take three months or more from start to finish – but in this case, if we find a match with a donor on the list, practically the product can be sent to us the next day.”
For patients suffering from leukemia and other serious illnesses, this immediate availability could make the difference between life and death, Abidi said.
Consent and regulation
According to Caldwell, donors on Osium’s platform are “dual consent.”
The first step is for the person to agree to organ donation, which usually happens at a D.M.V.
According to the Health Resources and Services Administration, nearly 170 million people are registered to become donors.
Osium also follows a second consent process after the death of the donor.
“We also seek consent from the family to confirm that their loved one wishes to provide these organs,” Caldwell said. “In the vast majority of cases, family members will respect that decision.”
According to the Health Resources and Services Administration, nearly 170 million people are registered to become donors. (iStock)
Because cryopreserved bone marrow is not a drug — and is not significantly different from living donor bone marrow — it is not Subject to approval “By the Food and Drug Administration (FDA),” Caldwell said.
“The FDA does not regulate bone marrow transplants from living donors — they consider it the same as organ transplants,” he said.
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After finalizing its product and facility, Osium sent the process and data to the FDA, which confirmed that its inspection was not required.
“But we’re still doing the study, in order to generate a data set that will enable bone marrow transplant doctors to use this product for their patients,” Caldwell said.
looking ahead
After the first transplant was performed for a patient in Michigan, a second transplant was performed in Utah, and several more are planned, Caldwell said.
“We are very excited about the results from these first two patients,” he said.
Osium now plans to publish the data to increase enrollment in clinical trials.
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The ultimate goal, Caldwell said, is to “dramatically expand” the reservoir of bone marrow stem cells obtained from deceased organ donors to help fight cancer.
“Leukemia is a treatable cancer if you find a donor in time,” Caldwell said.
“We don’t want anyone to die because of a logistical problem.”
“We don’t want anyone to have to die because of a logistical problem. We want to create a world where every person in need can get help. Bone marrow transplant I can get one.”
Caldwell said that although Osium’s platform is currently focused on treating blood cancers, there are other ways it could benefit patients in the future.
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“Clinical banks of stem cells also have many other applications, including performing organ transplants without immunosuppression and preventing organ rejection,” he added.
“As more data become available to show safety in a larger number of patients and donors, this will certainly be a very good achievement,” Abedi said.
