A deceased organ donor provides the first-ever bone marrow transplant to a leukemia patient.

Finding a match for bone marrow transplants can take months or years for patients with certain types of cancer, blood disorders, and other diseases, but these transplants can be life-saving.

Annually, approximately 18,000 individuals in the U.S. receive a diagnosis of life-threatening illnesses that can be cured through transplanted bone marrow.

Ossium Health has developed a program that utilizes deep-frozen bone marrow from deceased organ donors to increase the chances of life-saving treatment for patients.

A 68-year-old woman from Michigan received a bone marrow transplant from an unrelated organ donor for blood cancer treatment after a four-month search for a matching donor failed earlier this year.

The patient, who had acute myeloid leukemia, is now rapidly recovering after receiving a transplant at Henry Ford Health in Detroit, Michigan.

Muneer Abidi, M.D., a hematologist at Henry Ford Health, explained to Planet Chronicle Digital during a phone conversation that we were nervous about using a bone marrow from a cadaver because there was no precedence for it in clinical trials for Ossium's bone marrow product.

"Despite some apprehension and anxiety, we were pleasantly surprised and happy when she recovered her stem cell count as expected, with results very similar to those of a normal, healthy donor."

Bone marrow barriers

According to Kevin Caldwell, CEO of Ossium Health, a bone marrow transplant is the final treatment option for blood cancer patients.

A blood cancer patient seeking a bone marrow transplant must locate a suitable living donor who closely matches their genetic profile.

"We were nervous about it because there was no precedence of using a bone marrow from cadaver."

Unlike other organs that can be transplanted from one person to another with minimal genetic matching, bone marrow requires a very close genetic match.

And the process isn’t easy, he noted.

Caldwell stated that the donor must be willing, able, and ready to provide bone marrow to a stranger, undergo a hip drilling procedure, and have their bone marrow aspirated or stem cells mobilized, all while taking time off work and making a significant sacrifice to benefit someone they've never met.

There is also the challenge of timing.

Caldwell stated that it can take several months to locate a suitable donor who is healthy, willing to donate, and genetically compatible, which is a timeframe that blood cancer patients often do not have.

Approximately 55% of blood cancer patients undergo a successful transplant, while the remaining 45% do not survive.

According to Abidi, a common challenge is finding a perfectly matched donor for minorities, particularly African-Americans.

"The problem worsened during COVID," he told Planet Chronicle Digital.

Meeting the need

Ossium Health created a bone marrow bank using donated organs to tackle problems.

Caldwell stated that there is a network of 27 organ procurement organizations in the United States that handle organ donation, obtain consent, and perform recoveries.

"We've trained the staff on how to recover bone marrow, constructed a facility for processing and manufacturing doses, and cryopreserved it on-site."

Just as organs such as hearts, livers, lungs, kidneys, corneas, and skin have been donated for decades, the objective is to recover and donate bone marrow, Caldwell stated.

The life-saving stem cells present in the vertebral bodies of these donors were not being used before Ossium.

"Despite their consent to organ donation, these people's organs would still be discarded."

A clinical trial called PRESERVE I has been launched by Ossium, which provides bone marrow to acute leukemia patients in need of an allogeneic (genetically similar) transplant.

In May 2024, the first patient to join the trial in Michigan received her transplant through Ossium's HOPE Program.

"Thanks to our bone marrow unit, she is now alive and well and recovering from her blood cancer," Caldwell stated.

"This case underscores the significance of this new option for patients with urgent requirements."

Benefits of cryopreserved bone marrow

The largest advantage of using bone marrow from deceased donors, according to Caldwell, is that a greater amount of the organ can be utilized.

"We can recover more of our donors' bone marrow than we could ethically take from a living person who still needs it, as they no longer require it," he stated.

According to Caldwell, on average, they can obtain two to five times as many cells from an organ donor as from a living person.

"Our donors don't need their bone marrow anymore, so we're able to recover much more of it than we could ever ethically take from a living person."

"One donor could potentially save multiple lives through multiple transplants."

Stem cells may be able to provide a larger dose, which improves patient outcomes.

For the first time, doctors have the option to choose the dosage they want to administer to their patients, similar to when they prescribe medication, according to Caldwell, as reported by Planet Chronicle Digital.

The immediate availability is also a major benefit, Abidi added.

He stated that the product has been collected, is currently available, and we are aware of its storage location.

"If a donor match is found in the inventory, the product can be shipped to us the next day after identifying a healthy donor, which may take up to three months or longer from start to finish."

Immediate access to stem cell transplants can be a lifesaver for patients with aggressive diseases like leukemias, according to Abidi.

Consent and regulation

According to Caldwell, the donors on Ossium's platform are "double-consented."

Typically, the first step for a person to become an organ donor is to agree to it at the DMV.

According to the Health Resources & Services Administration, approximately 170 million people are registered as donors.

Ossium also follows a second consent process after the donor’s death.

""In most cases, family members will respect their loved one's decision to donate organs," Caldwell stated."

The cryopreserved bone marrow, being not a drug and not significantly different from living donor bone marrow, does not require FDA approval, according to Caldwell.

"Organ transplants and bone marrow transplants from living donors are treated similarly by the FDA," he stated.

The FDA confirmed that Ossium's product and facility did not require its oversight after the company finalized them and submitted the process and data.

Caldwell stated that although we are conducting the studies, our primary objective is to create a data set that will enable bone marrow transplant doctors to utilize this product for their patients.

Looking ahead

Caldwell stated that since the first transplant in Michigan, a second one was done in Utah, and numerous others are planned.

He expressed excitement about the results from the initial patients.

The clinical trials will receive a boost from Ossium's decision to release the data.

The objective, as Caldwell stated, is to "significantly increase" the supply of bone marrow stem cells from organ donors to combat cancer.

If a donor is found in time, leukemia can be treated and cured, according to Caldwell.

"We don't want anyone to die because of a logistical problem."

"Our goal is to prevent anyone from dying due to logistical issues related to bone marrow transplants, and to create a world where almost everyone who requires one can access it."

Caldwell stated that although Ossium's platform is currently geared towards treating blood cancers, it has the potential to benefit patients in other ways in the future.

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"A clinical bank of stem cells can be used for various purposes, such as performing organ transplants without immunosuppression and preventing organ rejection," he stated.

As more data becomes available to demonstrate the safety of larger numbers of patients and donors, this will undoubtedly be a valuable addition.