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Bone marrow transplants can be lifesaving for patients suffering from certain types of cancer, blood disorders, and other conditions, but for many patients it can take months or years to find a match. There is.
Each year, approximately 18,000 people in the United States are diagnosed with a fatal disease that can be successfully treated with donated bone marrow.
To increase the chances of these patients receiving life-saving treatment, bioengineering company Ossium Health has created a program to donate frozen bone marrow from deceased organ donors.
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Earlier this year, a 68-year-old Michigan woman received a bone marrow transplant from an unrelated organ donor to treat her blood cancer after a four-month search to find a compatible donor failed. He became the first patient.
Each year, approximately 18,000 people in the United States are diagnosed with a fatal disease that can be successfully treated with donated bone marrow. (St. Petersburg)
The patient had acute myeloid leukemia and underwent a transplant at Henry Ford Hospital in Detroit, Michigan. Doctors say she is now “recovering rapidly.”
“We were nervous because there was no precedent for using bone marrow from a cadaver,” Dr. Munir Abidi, a hematologist at Henry Ford Hospital who led clinical trials of Ossium's bone marrow product, told Fox News Digital by phone. he said. conversation.
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“So, although we were a little anxious and worried, we were also pleasantly surprised and happy when she made a full recovery.” [stem cell] This count is very similar to the expected duration in a normal, healthy donor. ”
bone marrow barrier
Ossium Health CEO Kevin Caldwell said bone marrow transplants are the final treatment for blood cancer patients.
In the current medical system, blood cancer patients who need a bone marrow transplant must find a suitable volunteer with a healthy lifestyle.
“We were nervous because there was no precedent for using bone marrow from a cadaver.”
“Unlike many other organs that can be harvested from one person and transplanted into almost anyone of the same size, bone marrow is genetically very rigorous,” Caldwell said in a conversation with FOX News Digital. It needs to match.”
And the process is not easy, he noted.
“The donor must be ready, willing, and able to donate bone marrow to a complete stranger, have a hole drilled in their lower back, aspirate the bone marrow, mobilize stem cells, and do so in large numbers. “You have to take days off work and make meaningful sacrifices to benefit people you've never met,” Caldwell said.
Biotechnology company Ossium Health has created a new program to donate frozen bone marrow from deceased organ donors. (Ossium Health)
There is also the issue of timing.
“It can take months to find someone who is healthy enough, willing to donate, and genetically compatible, but these blood cancer patients often don't have that time.” A lot,” Caldwell said.
He noted that about 55% of blood cancer patients have successful transplants. The remaining 45% do not, and most of them do not survive.
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Another widespread problem, Abidi said, is the difficulty for minorities, especially African Americans, in finding a perfect donor match.
“COVID-19 has made the problem even worse,” he told Fox News Digital.
meet your needs
To address these issues, Ossium Health has developed a bone marrow bank harvested from organ donors.
“We have created a network of 27 organ procurement organizations across the United States that manage organ donations, obtain consent, and perform retrieval,” Caldwell said.
Ossium has begun a clinical trial called PRESERVE I to donate bone marrow to patients with acute leukemia who require allogeneic (genetically similar) transplants. (Ossium Health)
“We train them how to harvest bone marrow, build a facility to process and manufacture doses for patients, and cryopreserve them on-site.”
Caldwell said the goal is for bone marrow to be recovered and donated like other organs, such as the heart, liver, lungs, kidneys, corneas and skin.
“Prior to Ossium, the bone marrow from these donors, the life-saving stem cells present in the donor's vertebral bodies, was not used,” Caldwell said.
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“Despite the fact that these people have agreed to donate their organs, they will be discarded.”
Ossium has begun a clinical trial called PRESERVE I to donate bone marrow to patients with acute leukemia who require allogeneic (genetically similar) transplants.
The first patient enrolled in the trial, a Michigan woman, received a transplant in May 2024 through Ossium's HOPE program.
Ossium's CEO said the ultimate goal is to “dramatically expand” the pool of bone marrow stem cells from deceased organ donors to help fight cancer. . (St. Petersburg)
“She is now alive and well and on a great recovery trajectory from her blood cancer because we had a bone marrow unit that was able to fit her and save her life,” Dr. Caldwell said. Ta.
“This case illustrates the importance of this new option for patients with urgent needs.”
Benefits of cryopreserved bone marrow
There are several advantages to using bone marrow from deceased donors, Caldwell said. The biggest advantage is that more organs can be used.
“Because our donors no longer need bone marrow, we can recover far more bone marrow than we could ethically take from a living person who still needs bone marrow to survive,” he said. spoke.
On average, researchers can harvest two to five times more cells from an organ donor than from a living person, Caldwell said.
“Because our donors no longer need bone marrow, we can recover much more bone marrow than we could ethically collect from a living human being.”
“That may mean we can perform multiple transplants from one donor and save multiple lives.”
In some cases, it may be possible to provide larger quantities of stem cells, which improves patient outcomes.
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“For the first time in history, doctors can choose the dose they want to give their patients, just like they would determine the dose when prescribing a drug,” Caldwell told FOX News Digital.
Abidi added that immediate availability is also a big advantage.
“The product is already available and has been recalled, and we know exactly where it is stored,” he said.
Ossium has built a facility to process and manufacture and cryopreserve quantities of bone marrow for patients on-site. ” (Ossium Health)
“If we approach a healthy donor, it can take up to three months or more from start to finish. But in this case, if we have identified a match in our inventory, we can have product available virtually the next day. I can ship it.”
For patients with leukemia and other malignant diseases, this immediate availability could mean the difference between life and death, Abidi said.
consent and regulation
Caldwell said donors on Ossium's platform have “double consent.”
The first step is agreeing to become an organ donor, which is usually done at the DMV.
According to the Health Resources and Services Administration, about 170 million people are registered as donors.
Ossium also goes through a second consent process after the donor's death.
“We also get consent from families to make sure their loved one wants to donate these organs,” Caldwell said. “In most cases, families will respect the decision.”
According to the Health Resources and Services Administration, about 170 million people are registered as donors. (St. Petersburg)
Cryopreserved bone marrow is not a drug and is not significantly different from living donor bone marrow, so it is not subject to Food and Drug Administration approval, Caldwell said.
“The FDA does not regulate bone marrow transplants from living donors. The FDA considers it the same as an organ transplant,” he said.
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After Ossium completed its product and facility, it submitted its processes and data to the FDA, which determined that its oversight was not required.
“But we're doing research anyway and creating a data set that will allow bone marrow transplant physicians to use this product on their patients,” Caldwell said.
Looking to the future
Since the first transplant was performed on a patient in Michigan, a second transplant has been performed in Utah, and more are planned, Caldwell said.
“We're really excited about the results of the first few patients,” he said.
Ossium now plans to make the data publicly available to facilitate enrollment in clinical trials.
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The ultimate goal is to “dramatically expand” the pool of bone marrow stem cells from deceased organ donors to help fight cancer, Caldwell said.
“Leukemia is a treatable cancer if you can find a donor in a timely manner,” Caldwell said.
“We don't want anyone to die due to logistical problems.”
“We don't want anyone to die due to logistical problems. We want to see a world where nearly everyone who needs a bone marrow transplant can receive one.”
Although Ossium's platform is currently focused on treating blood cancers, it could potentially benefit patients in other ways in the future, Caldwell said.
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“Having access to a clinical bank of stem cells has many other applications, such as performing organ transplants without immunosuppression and preventing organ rejection,” he said.
Abidi added: “This will certainly be a very nice addition as more patient and donor safety data becomes available.”
