Low back pain remains one of the most persistent and costly challenges in healthcare. The World Health Organization (WHO) estimates that 619 million people experienced low back pain in 2020, with cases projected to rise to 843 million by 2050. It is also the leading cause of disability globally, underscoring the need for treatments that go beyond short-term symptom control.
For patients with degenerative disc disease, current treatment options often range from physical therapy, anti-inflammatory medications and steroid injections to opioids or surgery. While these approaches can provide relief, they generally do not repair the damaged disc or address the underlying biology driving pain and loss of function.
That gap is helping shape a new phase in regenerative medicine, one focused on targeting the root cause of diseases and through robust clinical programs.
CEO
BioRestorative Therapies
“I think regenerative medicine is transitioning from early-stage promise to clinically rigorous development,” Lance Alstodt, CEO of BioRestorative Therapies, told Xtalks. “We’re seeing stronger trial designs, clearer regulatory paths and a growing focus on therapies that address the underlying biology of disease rather than just the symptoms.”
BioRestorative is developing BRTX-100, an investigational autologous, hypoxically cultured mesenchymal stem cell therapy for chronic lumbar disc disease.
For Alstodt, degenerative disc disease represents a clear example of where regenerative approaches may shift the treatment paradigm.
“The current treatment approaches for degenerative disc disease are largely focused on symptom management rather than addressing the underlying cause of the pain,” he said. “These options may provide temporary relief, but they do not repair the damaged disc itself.”
The clinical question is therefore not only whether a cell therapy can reduce pain, but whether it can demonstrate meaningful, durable improvements in function in a rigorously controlled setting.
According to Alstodt, key endpoints in regenerative medicine trials for musculoskeletal pain should include reductions in pain, improvements in function and durability of response over time. The endpoints should be grounded in clinical relevance and scientific rigor, he explained.
Durability is especially important in chronic pain conditions, where temporary improvements may not translate into long-term clinical or economic value. Alstodt noted that payers are likely to focus closely on whether regenerative therapies can sustain benefit over time, particularly compared with existing standards of care.
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Clinical trial design is also evolving. In heterogeneous conditions like chronic back pain, patient selection is central to interpreting results. Trials must define the patient population carefully, use rigorous control arms and follow patients long enough to determine whether treatment effects persist.
“Trials are becoming increasingly more sophisticated,” Alstodt said, pointing to greater emphasis on appropriate patient selection, longer follow-up periods and more robust controls. These design elements, he said, are helping generate higher-quality data and build confidence in clinical outcomes.
For autologous cell therapies, however, clinical evidence is only one part of the development challenge. Because the therapy is derived from a patient’s own cells, manufacturing consistency, quality control and scalability are critical.
These factors are also central to regulatory review. Alstodt said agencies require comprehensive data across safety, efficacy and manufacturing processes, making regulatory alignment and “disciplined execution essential across clinical and operational functions” as cell therapies move through clinical development.
The broader promise of regenerative medicine is centered on the goal of moving chronic disease care from repeated interventions toward repair or restoration of function. In chronic pain, that could mean reducing reliance on long-term pharmacotherapy, repeated injections or invasive procedures.
The opioid crisis adds urgency to this shift. While US overdose deaths have declined from recent peaks, CDC provisional data continue to show that drug overdose deaths remain a major public health burden, with national estimates updated monthly and subject to reporting delays.
“Regenerative medicine has the potential to fundamentally be paradigm shifting within chronic disease management by moving from symptom control toward restoring function,” Alstodt said.
BioRestorative is also exploring regenerative approaches beyond spine disease through its ThermoStem platform, a preclinical metabolic program focused on brown adipose-derived stem cells and exosomes. The company says the platform is designed to target obesity and metabolic disorders by generating brown adipose tissue-like activity, with the goal of influencing metabolic homeostasis.
Still, Alstodt emphasized that the field’s progress depends on doing the development work properly. Regenerative medicine has faced skepticism in the past, particularly from unproven commercial offerings that moved ahead of strong clinical data. The next phase, he suggested, will be defined by companies that can demonstrate safety, reproducibility and durable benefit through formal regulatory pathways.
“Innovation takes time,” he said. “If you want something really great, you have to put in the time.”
For degenerative disc disease, that means proving that a minimally invasive regenerative therapy can do more than temporarily reduce pain. It must show that it can improve function, sustain benefit and be manufactured consistently enough for broader clinical use.
If successful, regenerative medicine could become a more prominent part of chronic disease management, not as a replacement for every existing therapy, but as a new category of treatment aimed at addressing disease biology more directly.
For patients with degenerative disc disease, that would represent a meaningful step beyond symptom management toward restoration of function.
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