BioRestorative Therapies Inc. BRTX, a stem cell-focused biotech, says it wants to shift the paradigm of how doctors treat chronic pain in hopes of giving patients an option that’s effective, safe and capable of generating long-term relief.
With a Phase 2 trial of its leading drug candidate BRTX-100 underway, BioRestorative reports developing a stem cell-based treatment that treats back pain by healing the actual source of that pain.
For Millions Of Americans, Back Pain Might Be Far More Than Just A Back Problem
According to the U.S. Pain Foundation, the most common chronic pain condition is back pain, affecting about 16 million adults. But the number climbs to 65 million when you include those who suffer from episodes of acute back pain.
The condition is so debilitating that Georgetown University’s Health Policy Institute estimates 83 million days of work are lost every year as a result of back pain.
In addition to lost productivity, back pain takes a psychological and social toll as well. Seventy-two percent of people with back pain also reported symptoms of depression and anxiety, including worthlessness, hopelessness and trouble sleeping.
They’re also more than three times as likely to limit or avoid social and recreational activities, which can worsen the sense of isolation and hopelessness and lead to decreased physical activity that can end up making pain symptoms worse.
Patients in a chronic state can become so determined to find relief that they can end up dependent on addictive painkillers or undergo repeat surgeries with limited success rates.
Stem Cell Therapy May Hold A Key To Meaningful, Long-Term Pain Relief
Of those 65 million Americans who experience acute or chronic back pain, more than 30% of cases will be linked to a degenerative disc disease. The discs that make up the human spine undergo wear and tear as people age, no matter who they are or how healthy their lifestyle is.
However, for 30% of back pain sufferers, the damage is more than normal wear and tear. Discs can slip out of place, break or become brittle. When they do, the pain can be intense and unrelenting.
Over-the-counter painkillers like Bayer AG’s BAYRY Aleve or more powerful muscle relaxers like Novartis AG’s NVS Baclofen can dull the pain for a while, but they can’t push a slipped disc back into place or repair a fracture. Spinal surgeries are available, but they’re often invasive and can offer limited relief.
Lumbar fusion, for example, is the most common surgery for back pain. But one long-term study of 1,450 back pain sufferers found that 36% of lumbar fusion patients experienced complications from the surgery. Meanwhile, 76% of those who got surgery continued to rely on opioids afterward, with 41% even increasing usage.
That frustrating situation has motivated many researchers to look for more permanent solutions to back pain and other musculoskeletal pain conditions.
Perhaps one of the most exciting areas of pain research is stem cell therapy. Rather than quieting the pain signals or surgically modifying the spine, cell therapies have the potential to actually repair damaged tissue and bone.
Some of the treatments in development have the potential to start acting in a matter of weeks and continue improving symptoms up to 12 months after treatment. In longer-term studies, those improvements were still present five years after treatment.
BRTX-100 Delivers Stem Cells Directly To The Source Of Back Pain
BioRestorative reports its BRTX-100 is developed using the patient’s own stem cells, which are manufactured under low oxygen to prepare them for the harsh disc microenvironment and injected directly into the damaged disc during a noninvasive 20-minute procedure. Other clinical trials of similar treatments using stem cells have yielded positive results.
A smaller human study of donor-derived stem cells, for example, saw “quick and significant improvement” in function in treated patients compared to controls. A pilot study using patient-derived stem cells reported rapid improvements in pain and function across treated patients.
Building on a growing body of positive data, BioRestorative was granted authorization by the Food and Drug Administration to conduct a Phase 2 clinical trial to treat chronic lumbar disc disease. The Phase 2 trial, which began enrolling patients in June, will include up to 99 patients with lumbar disc disease and administer a single injection of BRTX-100 (or a control) to evaluate the safety and efficacy of the novel drug candidate.
While researchers aim to reach the primary endpoint of at least a 30% decrease in pain and 30% increase in function by week 52, they will continue following up with patients for an additional 12 months to evaluate the long-term safety and preliminary efficacy of BRTX-100.
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