FDA Approves Human Trial of Cellular Transplant to Cure Paralysis

By JEFFREY KLUGER

In the early winter of 1988, I travelled to Miami to visit Marc Buoniconti. He was 24 years old at the time, and in many ways looked quite fit — full of energy, chattering on about his plans, exactly what you’d expect from a person his age. But Buoniconti wasn’t fit. He was in a wheelchair and hadn’t moved a muscle below his shoulders since fracturing his spine between the third and fourth cervical vertebrae in a college football game in October 1985.

Marc Buoniconti

By the time I met him, he had already done the grueling work of weaning himself from his respirator — training new muscles and learning new techniques to breathe on his own. And that freedom allowed him to assume the job of point man for the Miami Project to Cure Paralysis, an organization co-founded by Buoniconti; his father, NFL Hall of Famer Nick Buoniconti; the University of Miami; and a handful of local surgeons.

“I was never in denial about my injury,” Marc Buoniconti told me at the time. “When you can’t move, you move through that phase pretty fast.” But the absence of denial did not mean the absence of hope. Buoniconti was adamant that he would dedicate his life to getting out of his chair and helping the 300,000 other Americans living with spinal-cord injury do the same. In the meantime, he’d keep himself as fit as possible. “When the cure comes,” he said, “I plan to be ready.”

Buoniconti is now a 45-year-old man with a degree in psychology, still with the Miami Project — and still in a wheelchair. But the cure he spoke of 27 years ago just got a very big step closer. On Tuesday morning, Miami Project doctors convened a press conference to announce that the U.S. Food and Drug Administration (FDA) had just granted them a green light to begin Phase 1 human trials for a new surgical technique in which nerve cells from the leg would be transplanted to the spine of newly paralyzed patients in the hope that they would grow — restoring at least some function and sensation.

“I am more optimistic now than I have ever been,” says Buoniconti. He has reason to be.

diagram of human body with 4 nervous systems, Cranial, Peripheral, Central & AutonomicWhat makes spinal-cord injuries as devastating as they are is that everything about them plays out in absolutes: they are instantaneous, utterly disabling and horribly permanent. That last fact has always presented both a puzzle and an opportunity. Nerves in the peripheral nervous system (PNS) — those that carry signals in an arm or leg, say — are able to regenerate after injury. That’s why you can badly lacerate a finger and retain full use of it. The central nervous system (CNS) is a different matter. An injured spine remains an injured spine, period. Find and harness what it is that makes things so different in the PNS and you just might get a wounded spine to heal.

As researchers learned, there are a lot of things that drive peripheral regrowth, but perhaps the most important are known as Schwann cells, which are not nerve cells themselves but a kind of attendant, helping neurons regrow myelin — the fatty insulation that covers nerve strands — and otherwise stay healthy and functioning. For some years, Miami Project scientists have been transplanting Schwann cells from the legs of paralyzed rats, mice, pigs and primates to the site of the spinal injury and have been astonished at the results: in many cases, the animals recovered 70% of the lost sensation and function. That is exactly 70% more than most spinal injured patients have been told to hope for.

What the FDA is permitting — and what the Miami Project announced today — is preliminary, or Phase I, trials of Schwann cell transplants in humans. Under the new study, researchers will seek eight volunteers with fresh spinal injury at the thoracic level — farther down the spine than the neck, at a point at which damage can lead to paraplegia rather than quadriplegia. Schwann cells will then be harvested from each patient’s leg, grown and purified in petri dishes for 26 to 40 days, and transplanted into the spine. The patients will be followed for at least a year to determine what, if any improvement they’ve experienced, or what, if any, problems they’ve encountered.

Read more at:  TIME-Healthland

Trish

TRISH ROBICHAUD is an award-winning Life & Business Coach who lives with MS. She teaches women living with chronic illness or disability how to honour and accommodate their health as a foundation for life. Book a free OPTIMAL HEALTH or HEALTHY BUSINESS Strategy Session at www.ChangingPaces.com or www.MSrelief.com.

4 Comments:

  1. Hi Linda,
    Great article. I just wanted to thank you for all your support. You are a great friend. Also, you should check out the post I wrote on askshanae.com thanking you.
    Cheers,
    Shanae

  2. Hi Linda,
    Great article. I just wanted to thank you for all your support. You are a great friend. Also, you should check out the post I wrote on my askshanae blog thanking you.
    Cheers,
    Shanae

    • Hey Shanae, I will check it out! You really should get CommentLuv plug in… it’s free and then whenever you leave a comment you’re post will show so it will be easy for people to link on it! I wrote a blog about it on my other site, you can check it out right here: http://lindagraceonline.com/getting-the-most-out-of-wordpress-commentluv-plugin/ I know Andy Bailey has made a ton of changes to CommentLuv since I made this tutorial video so it won’t look exactly the same. He still has a free version so I suggest you don’t get sucked into spending any money at this time. I know how busy you are and it will well worth your time getting commentluv on your blogs!
      ~Linda
      oh yeah and you’re welcome! I had so much fun with you!

  3. I like reading a post that can make people think.
    Also, thanks for permitting me to comment!

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