The Afterlife of Afterbirth – MedPage Today

Laura Wilson didn't know about placenta donation until she was on the operating table.

"I had a cesarean, so they came in while I was being prepped for surgery," Wilson says in a YouTube video. "It was something I hadn't heard of before."

But when she was told placental tissue could be used to help people suffering from serious wounds, the mother of three boys quickly signed off on the consent forms.

"It was fun to think, ok, this could go to some good use instead of just going with everything else" in the medical waste bag, she says.

Wilson isn't the only mother to suddenly face a decision about placenta donation in the operating room. In an article on the motherhood website Scary Mommy, Caila Smith said she was in the hospital about to have an emergency C-section when a nurse asked her if she wanted to donate her twins' placentas. Another woman described getting a call from her doctor's office after scheduling her C-section and being asked to donate.

While most pregnant women have heard about cord blood donation, far fewer are familiar with placenta donation which can actually refer to the placenta, umbilical cord, and amniotic fluid, or "birth tissue." All are now sought as rich sources of stem cells. The eleventh-hour decision raises questions about just how informed patients' consent actually is, and what their donations are ultimately used for, particularly given the explosion in stem cell clinics offering questionable therapies.

"If women are being approached when they're in labor, about to go into a C-section, it's not the optimal time to be making decisions like that," Leigh Turner, PhD, a bioethicist at the University of Minnesota who has tracked the rise in stem cell clinics, told MedPage Today.

"Maybe they think it's for altruistic purposes," he added. "They may not realize there's a large for-profit marketplace out there."

It's difficult to track what donations are actually used for, although placental material does have seemingly legitimate applications in wound care and research. Still, those markets can be lucrative information that isn't usually offered to a mother, who is not compensated for the organ, when she is making her decision.

As more hospitals launch placenta donation programs, more mothers may be faced with the choice at an emotional, vulnerable time in their lives.

"I wanted to do this in case one day my boys would need this," Wilson says in the video, which was posted to YouTube by a company called Birth Tissue Recovery to promote its placenta donation program.

Rise in Placenta Donations

St. David's Medical Center in Austin, Texas, launched its placenta donation program about a year and a half ago in partnership with GenCure, a company that describes itself as non-profit and says it "applies advances in regenerative medicine to help heal patients suffering from trauma, disease or the aging process" on its website.

GenCure's placenta donation program involves collecting the placenta and the umbilical cord, according to spokesperson Ashley Frolick. The company also collects cord blood through the Texas Cord Blood Bank, which it owns.

In most cases, mothers are told about the option to donate when they arrive at the hospital, Frolick said, although they are only eligible if they are having a C-section, which is often an emergency situation.

Michelle Kocks, RN, coordinator of the placenta donation program at St. David's, said patients are persuaded by the fact that they're helping others, and because the placenta will otherwise be discarded as medical waste -- a potential incentive for hospitals to run programs, as they would otherwise have to pay for medical waste disposal. (Hospitals are uniformly mum about why, exactly, they agree to facilitate donations that go to outside entities, or whether money changes hands.)

"Once [women] learn about the benefits ... they love being able to be a part of the program," Kocks told MedPage Today, adding that about 20% of eligible women who undergo C-section deliveries become donors. Frolick said nurses and doctors are not paid for referrals, and neither are the women who are giving birth.

Other hospitals are launching placenta donation programs. Rochester General Hospital added theirs in July, and Mount Carmel St. Ann's Hospital in Westerville, Ohio, had its first donation in April. Both are working with MTF Biologics, which also claims non-profit status and says it focuses on bone and skin grafts.

St. Joseph Mercy in Ann Arbor, Michigan, launched its program this summer in partnership with Gift of Life Michigan, the first hospital in the state to do so.

Other hospitals with new programs include Sisters of Charity Hospital in Buffalo, New York, which works with ConnectLife (formerly UNYTS); and Maple Grove Hospital in Minnesota, which works with for-profit MiMedx.

MiMedx has been plagued by scandals including charges involving its marketing and accounting practices, and allegations that it shipped more product than had been ordered and booked that as sales. This summer, the Department of Veterans Affairs advised its facilities not to use injectable amniotic tissue products from the company for not meeting purity and sterility standards. The VA also warned against using such products for managing plantar fasciitis, tendonitis, or osteoarthritis "since evidence is currently limited or lacking" for their efficacy.

MiMedx runs placentadonation.com through its subsidiary MiMedx Tissue Services.

Loralei Thornburg, MD, an ob/gyn at the University of Rochester Medical Center, said her institution discussed a placenta donation program with ConnectLife, but didn't create one because they treat too many high-risk cases.

"Most of the hospitals where you see it being done tend to [have] lower-risk, more normal populations," Thornburg said. "One of our lower-risk hospitals started looking into it ... because that's who's eligible. I do primarily high risk. They don't want a 28-week placenta with preeclampsia."

GenCure partners with six hospitals in Texas on placenta donation. Frolick said the birth tissue that it collects is provided to "partners who will then create therapeutic products that may be used to help treat burns, diabetic ulcers, traumatic injuries, and can go on to develop other FDA-approved therapies."

That could include stem cell therapies, Frolick said. These treatments have long taken advantage of a grey area in FDA regulation, which stipulates that human cell and tissue products are exempt from the extensive and expensive drug or biologic approval process as long as they meet certain criteria.

'It's Going to Be Marked Up and Sold Again'

Summa Health, a health system in northern Ohio, offers "placenta tissue injections" for "damaged tissue found in tendons, ligaments, inflamed tissue and degenerated joints."

A PubMed search reveals no studies of the therapy for any indication.

"I'm not aware of anything in this whole sector being shown to be effective or safe with good, solid data," stem cell researcher Paul Knoepfler, PhD, of the University of California Davis, told MedPage Today.

The rise in placenta and birth tissue donation parallels an increase in unregulated stem cell clinics around the country, with well over 1,000 today, up from 570 when Turner first started tracking them in 2016. The FDA has long waged war with these clinics, which purport to treat everything from pain to Parkinson's disease with stem cells. A federal judge handed the agency a victory in June when it ruled that FDA could block Florida-based U.S. Stem Cell from injecting patients with a stem-cell "extract" made from their own fat cells.

Given the ruling, Turner said clinics may shift from using fat or bone marrow to procure stem cells, to placental or birth tissue products -- also referred to as amniotic stem cell treatments -- especially since they can just be bought and injected. Also, they don't require collecting or processing material from patients.

But the amniotic stem cell supply chain isn't easy to trace.

"It's the part of the marketplace that's most obscured, and that we know the least about," Turner said.

Summa Health did not return a request for comment as to where it gets the material for its placenta tissue injections.

An investigation by ProPublica found that one company, R3 Stem Cell, sourced its amniotic stem cell products from Utah Cord Bank, which began as a private bank where parents stored cord blood and other birth tissue.

Apart from stem cell therapies, other uses of placental material such as wound care can also be lucrative, especially since these products also fall under FDA's "minimally manipulated" and "homologous use" requirements for human cell and tissue products, side-stepping the agency's costly and time-consuming approval process.

John Lantis, MD, a wound care expert at Mount Sinai Hospital in New York, said he's skeptical of claims that amniotic and placental skin grafts provide superior healing compared with regular skin grafts.

"The number of products out there delivering real stem cells is highly questionable," Lantis told MedPage Today. "No one knows if active placental tissues are better. No one has studied it in a meaningful fashion, so a regular skin graft may work just as well."

One of the most widely used products for lower extremity wounds, Lantis said, is EpiFix, which is made by MiMedx. It is synthesized from "dehydrated human amnion/chorion membrane" -- placental material -- according to the company's website. In 2013, the FDA warned the company about marketing the product without approval, which the firm eventually obtained.

If women knew more about the money, power, and scandal behind their donations, they might see donation differently, Turner said.

"What if women were given the full account, that some biobank is going to acquire it, process it, assign it value, and then it's going to be marked up and sold again," Turner said. "Some women might think twice."

2020-03-01T00:00:00-0500

last updated 01.03.2020

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The Afterlife of Afterbirth - MedPage Today