Skip to content

Uncategorized

New Evidence Review: Acupuncture’s Role in Managing Chemotherapy-Induced Nerve Damage

New Evidence Review: Acupuncture’s Role in Managing Chemotherapy-Induced Nerve Damage

A new evidence-based clinical guide published October 1, 2026, synthesizes the latest research on managing chemotherapy-induced peripheral neuropathy (CIPN), identifying acupuncture as one of the few interventions with consistent evidence of benefit, while flagging a popular supplement that a major trial found actually worsens the condition.

Performing acupuncture on a patients back.A close-up of a patient receiving acupuncture an treatment on the back.Acupuncture back treatment. Performing acupuncture on a patients back.A close-up of a patient receiving acupuncture an treatment on the back.Acupuncture back treatment. acupuncture needles being placed in a patient's hand in a calm clinical setting, soft natural light, warm and reassuring tone stock pictures, royalty-free photos & images

Table of Contents

  • What’s New
  • Where Acupuncture Fits In
  • A Supplement Warning Worth Noting
  • The Full Picture: Diet and Exercise
  • Why This Matters
  • Conclusion

What’s New

Published in NDNR (Naturopathic Doctor News and Review), the guide by naturopathic physician Dr. Esha Singh pulls together a 2026 network meta-analysis of 32 trials examining non-pharmacological interventions for CIPN — nerve pain, numbness, and tingling that affects up to half of patients receiving common chemotherapy drugs like taxanes and platinum agents, and persists six months or longer in roughly a third of survivors. The review is notable for taking a clear-eyed look at what the evidence does and doesn’t support, including calling out a commonly used supplement for doing more harm than good.

Where Acupuncture Fits In

Among non-drug options, acupuncture stands out. The 2026 network meta-analysis found that acupuncture-based interventions were the only treatment category to significantly reduce CIPN pain compared to control, with electroacupuncture emerging as the most effective variant in related network analyses. A multicenter randomized controlled trial cited in the review found acupuncture improved hand numbness, tingling, discomfort, pain, and overall physical function, with benefits typically appearing by the second week of treatment and lasting about six weeks. A separate 2024 meta-analysis of 21 studies and over 2,100 patients identified a consistent core set of acupuncture points used across trials — including LI4, LI11, and ST36 — giving practitioners a reproducible protocol rather than an ad hoc approach. That said, when ranked against other non-drug options by statistical strength, cryotherapy and exercise both outperformed acupuncture, suggesting it’s most effective as one part of a combined plan rather than a standalone fix.

A Supplement Warning Worth Noting

The guide’s most pointed finding concerns acetyl-L-carnitine (ALC), a supplement often used with the theoretical goal of protecting nerves. A randomized trial of 409 women receiving chemotherapy found that 1,000 mg of ALC taken three times daily significantly worsened neuropathy at 24, 36, and 52 weeks, with a two-year follow-up showing increased severe toxicity in the treated group. The 2020 ASCO guidelines, still current, recommend against ALC along with vitamin E, B vitamins, calcium/magnesium, and glutathione for CIPN prevention — a reminder that “natural” and “harmless” aren’t the same thing, and that de-prescribing can be as important a clinical tool as prescribing.

The Full Picture: Diet and Exercise

The guide also highlights dietary quality as a meaningful factor: a prospective study of colon cancer patients found that higher scores on a healthy-eating index corresponded to a 65% reduced risk of severe CIPN, with a Mediterranean-style, anti-inflammatory eating pattern showing the strongest associations. On the exercise side, a 2025 network meta-analysis of 24 trials found that combining aerobic, resistance, and balance training was the most effective non-drug strategy overall, with a landmark trial showing supervised balance training reduced the onset of CIPN by 50 to 70% compared to standard care.

Why This Matters

CIPN is one of the most common reasons chemotherapy doses get reduced or treatment gets stopped early, directly affecting cancer outcomes — so managing it well matters beyond just comfort. For integrative and acupuncture practices, this guide reinforces acupuncture’s place in oncology supportive care backed by a 2022 Society for Integrative Oncology-ASCO joint guideline, while also modeling the kind of evidence-based caution integrative providers should bring to supplement recommendations. It’s a useful example of how naturopathic and integrative care is increasingly expected to engage with rigorous, current evidence rather than general wellness claims.

Conclusion

The takeaway for practitioners is a coordinated, multimodal approach: acupuncture using an established point protocol, an anti-inflammatory diet, structured exercise with a balance-training component, careful supplement de-prescribing, and medication co-management where appropriate. No single intervention reverses established CIPN, but combined, evidence-based care meaningfully improves patients’ function and quality of life.

Sources

  • NDNR, “Chemotherapy-Induced Peripheral Neuropathy: An Evidence-Based Guide for Naturopathic Physicians” by Dr. Esha Singh, ND — Read here

FDA Grants RMAT Designation to CAR T Therapy Obe-Cel for Lupus and Lupus Nephritis

FDA Grants RMAT Designation to CAR T Therapy Obe-Cel for Lupus and Lupus Nephritis

The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to obecabtagene autoleucel (obe-cel), Autolus Therapeutics’ CAR T cell therapy, for the treatment of systemic lupus erythematosus (SLE) and lupus nephritis (LN). The designation, announced September 9, 2026, is based on Phase 1b data showing high rates of disease remission in patients with severe, treatment-resistant disease.

video thumbnail

Table of Contents

  • What Happened
  • From Blood Cancer to Autoimmune Disease
  • What the Phase 1 Data Show
  • What Comes Next
  • Why This Matters
  • Conclusion

What Happened

Autolus Therapeutics announced on September 9, 2026, that the FDA granted RMAT designation to obe-cel for systemic lupus erythematosus and lupus nephritis, based on Phase 1b data from the ongoing CARLYSLE trial. RMAT designation, created under the 21st Century Cures Act, is intended to accelerate development and regulatory review of regenerative medicine therapies, including cell therapies, for serious or life-threatening diseases, offering sponsors more frequent FDA interaction and potential eligibility for accelerated approval pathways.

From Blood Cancer to Autoimmune Disease

Obe-cel is a CD19-targeting autologous CAR T-cell therapy distinguished by a “fast off-rate” binding domain, designed to reduce the toxicity typically associated with CAR T treatment. It’s already an approved, commercially launched therapy: marketed as Aucatzyl, obe-cel received FDA, EMA, and MHRA approval for adult relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) and launched commercially in the US and UK in 2025. The RMAT designation marks Autolus’s push to extend the same CD19-targeting mechanism, which depletes B cells, into autoimmune disease, where errant B cells are believed to drive conditions like lupus.

What the Phase 1 Data Show

The CARLYSLE trial is an ongoing Phase 1 study evaluating obe-cel in patients with severe, refractory SLE who had exhausted other treatment options. Updated data presented at the American Society of Hematology Annual Meeting in December 2025 showed that among six patients treated at the selected 50-million-cell dose, five of six (83%) achieved remission according to the Definition of Remission in SLE (DORIS) criteria, and half achieved a complete renal response. All patients in the trial had refractory lupus nephritis, and four of six had significantly impaired kidney function at baseline. Responses and remissions were ongoing at a median follow-up of 8.9 months, with no dose-limiting toxicities, no immune effector cell-associated neurotoxicity syndrome (ICANS), and no high-grade cytokine release syndrome reported. Steroids were tapered to low maintenance doses in all patients by month six.

What Comes Next

Autolus has aligned with the FDA on the design of LUMINA, a pivotal Phase 2 trial in lupus nephritis with registrational intent, which is currently enrolling patients across five countries. The company expects to report data from LUMINA in 2028. A further Phase 1 CARLYSLE data update has been submitted for presentation at the American College of Rheumatology Annual Meeting in the fourth quarter of 2026.

Why This Matters

Systemic lupus erythematosus and lupus nephritis remain difficult to treat once patients become refractory to standard immunosuppressive therapy, and current options rarely produce durable, drug-free remission. The CARLYSLE data’s most notable signal is a “deep reset” of the B-cell compartment following a single CAR T infusion, raising the possibility that a one-time cellular therapy could induce lasting remission rather than requiring chronic immunosuppression. For the regenerative medicine field, obe-cel’s expansion from an approved oncology product into autoimmune disease is also a notable proof point for CAR T platforms more broadly: several other CD19-targeting cell therapies are now being tested in autoimmune indications following similar early signals of deep B-cell depletion and drug-free remission.

Conclusion

RMAT designation gives Autolus a more direct regulatory pathway as it moves obe-cel into pivotal testing for lupus nephritis, but with LUMINA data not expected until 2028, this remains an early-stage program. The scale of the CARLYSLE remission data, however, makes this one of the more closely watched CAR T programs moving into autoimmune disease.

Sources

  • GlobeNewswire / Autolus Therapeutics, “Autolus Therapeutics Announces FDA RMAT Designation Granted to Obe-cel for the Treatment of Systemic Lupus Erythematosus and Lupus Nephritis” — Read here
  • Autolus Therapeutics, “Autolus Therapeutics Presents Updated Clinical Data from the CARLYSLE Trial … at ASH Annual Meeting 2025” — Read here
  • StockTitan, “Autolus Gets FDA RMAT Designation for Obe-cel in Lupus” — Read here

The Russian Method: What the Research Says About Ozonated Saline IV Therapy

The Russian Method: What the Research Says About Ozonated Saline IV Therapy

Ozonated saline drips — widely known as the “Russian method” of IV ozone therapy — are having a moment of renewed scientific scrutiny. A 2025 cellular study on ozone’s anti-inflammatory effects and a 2026 published rebuttal challenging its clinical relevance have reopened debate over how this decades-old Eastern European technique compares to Western ozone protocols.

Ozone Therapy Treats Chronic Conditions Like Epstein-Barr Virus

Table of Contents

  • What the Russian Method Is
  • How It Differs From Major Autohemotherapy
  • What Recent Research Shows
  • A Live Scientific Debate
  • Why This Matters
  • Conclusion

What the Russian Method Is

The Russian method of ozone therapy refers to the intravenous drip infusion of ozonated physiological saline — sodium chloride solution that has been bubbled with medical-grade ozone gas immediately before administration. Rather than requiring blood to be drawn, ozonated, and reinfused, the ozone is dissolved directly into saline and delivered gradually into the bloodstream over roughly 15 to 30 minutes. The technique originated in the former Soviet Union and remains formalized by the Russian Association of Ozone Therapy as a core protocol, distinct from the “West European method” of major autohemotherapy used more widely in Western Europe, the US, and parts of Latin America.

How It Differs From Major Autohemotherapy

Major autohemotherapy involves drawing a patient’s own blood, mixing it with ozone/oxygen gas outside the body, and reinfusing it — a process requiring specialized equipment and closer procedural monitoring. The Russian method instead ozonates the saline carrier itself, delivering ozone “drop by drop, molecule by molecule” as the solution enters circulation. Proponents describe this as simpler to administer, requiring smaller needles suitable for patients with difficult venous access or on blood thinners, and eliminating the contamination risk associated with handling blood outside the body. The Russian protocol also characteristically uses lower ozone concentrations delivered over a longer duration, based on the rationale that repeated low-dose exposure produces a more consistent antioxidant response than a single high-dose exposure, which can diminish in effectiveness with repeated use.

What Recent Research Shows

A study published in Molecules in September 2025 by researchers at Sapienza University of Rome examined how ozonated saline solution affects microglial cells (the immune cells of the central nervous system) and endothelial cells in laboratory conditions. At low concentrations (1 and 5 μg/NmL), ozonated saline enhanced cell proliferation without toxicity and triggered an antioxidant response, upregulating protective genes including Nrf2 and SOD1. It also shifted microglial cells toward an anti-inflammatory profile, reducing inflammatory markers like iNOS and IL-1β while increasing anti-inflammatory markers like Arg-1 and IL-10. At the highest tested concentration (10 μg/NmL), however, viability dropped and cell death increased — a finding that underscores why dosing precision matters clinically.

A Live Scientific Debate

The study didn’t go unchallenged. Other researchers in the field published a formal comment disputing the clinical translatability of using isolated cell-line models (BV2 microglial cells) to draw conclusions about whole-body ozonated saline therapy. The original authors published a detailed rebuttal in May 2026, defending the BV2 model’s scientific standing by pointing to its use in thousands of peer-reviewed studies, including papers in Nature, Science, and The Lancet. This back-and-forth is a useful reminder that ozonated saline’s mechanism is still being actively debated in the peer-reviewed literature, even as clinical use continues to expand.

Why This Matters

For integrative practices offering ozone therapy, the Russian method’s growing use in the US reflects real practical advantages — patient comfort, simpler logistics, and a gentler dosing profile that may suit patients who can’t tolerate autohemotherapy. But the current evidence base remains mostly preclinical (cell and animal models) and small pilot studies, rather than large randomized controlled trials in humans. The dose-dependent findings in the 2025 Molecules study are a useful clinical caution: what works as a low-dose anti-inflammatory stimulus can become cytotoxic at higher concentrations, reinforcing why ozone concentration and duration protocols matter and shouldn’t be improvised.

Conclusion

The Russian method remains a widely used but still scientifically contested approach within ozone therapy. Ongoing mechanistic research, and the active peer-review debate around it, suggest the field is moving toward better-defined dosing standards rather than settled consensus — worth watching as more rigorous clinical trials emerge.

Sources

  • Armeli, F. et al., “Ozone Saline Solution Polarizes Microglial Cells Towards an Anti-Inflammatory Phenotype,” Molecules, 2025 — Read here
  • Armeli, F. et al., “Reply to Franzini et al. The Translational Medicine Regarding Ozone in Saline Solutions,” Molecules, 2026 — Read here
  • MedOzons, “The Russian Technology of Ozone Therapy” — Read here

FDA Grants RMAT Designation to Personalized Stem Cell Therapy for Parkinson’s Disease

Neural Stem Cell Therapy Neural Stem Cell Therapy or Neuroregenerative Regenerative Medicine injected to regenerate brain tissue for neurodegenerative diseases medical illustration close up macro view. neurosurgery brain cell therapy stock pictures, royalty-free photos & images

The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to sasineprocel, Aspen Neuroscience’s investigational autologous cell therapy for Parkinson’s disease. The designation is based on encouraging early safety and activity data from the company’s ongoing Phase 1/2a ASPIRO trial.

Table of Contents

  • What Happened
  • How Sasineprocel Works
  • What the Data Show
  • Why This Matters
  • Conclusion

What Happened

On July 30, 2026, Aspen Neuroscience announced that the FDA granted RMAT designation to sasineprocel (ANPD001), its lead investigational cell therapy for Parkinson’s disease. The designation, created under the 21st Century Cures Act, confers the combined benefits of the FDA’s Fast Track and Breakthrough Therapy programs, including more frequent early interaction with FDA reviewers and potential eligibility for accelerated approval and priority review. Sasineprocel had previously received FDA Fast Track designation; RMAT status builds on that by opening a more structured regulatory dialogue ahead of the company’s planned Phase III study, expected to begin later in 2026.

How Sasineprocel Works

Sasineprocel is an autologous, personalized cell therapy, meaning it’s derived from each patient’s own cells rather than a donor. It’s manufactured by reprogramming a patient’s skin fibroblasts into induced pluripotent stem cells (iPSCs), then differentiating those into dopaminergic neuron precursor cells (DANPCs) — the type of neuron progressively lost in Parkinson’s disease. The cells are surgically delivered directly into the putamen, the brain region where dopamine signaling breaks down in PD, using image-guided delivery technology. The aim is to replace lost neurons and reconstruct disrupted neural circuitry, rather than simply managing symptoms with dopamine-replacement drugs like levodopa.

What the Data Show

The RMAT designation is supported by data from the ongoing Phase 1/2a ASPIRO trial, an open-label, multicohort, multicenter study evaluating sasineprocel in patients aged 50 to 70 with moderate-to-advanced Parkinson’s disease. Through 12 months of follow-up, the trial has shown no serious surgical adverse events, no severe graft-induced dyskinesia (an uncontrolled movement side effect seen with earlier-generation cell therapies), and no symptomatic hemorrhage or infarction. The most common adverse event reported in initial patients was swollen tongue.

Several patients also reduced their daily levodopa dose during the trial, which the company points to as an early signal consistent with disease-modifying activity rather than purely symptomatic benefit. The trial has dosed 15 patients across four cohorts to date, with the two most recent cohorts using a cryopreserved, commercial-ready cell formulation designed to support scalable manufacturing if the therapy advances toward approval.

Why This Matters

Parkinson’s disease currently has no approved treatment that addresses its underlying neurodegeneration — existing therapies manage symptoms but don’t replace the dopamine-producing neurons that are progressively lost. A personalized, patient-derived cell therapy designed to reconstruct that circuitry represents a materially different treatment strategy, and RMAT designation signals the FDA sees enough early promise to fast-track its regulatory pathway. For the broader regenerative and integrative medicine field, it’s also a notable proof point for autologous iPSC-derived cell therapy specifically, an approach that avoids the immunosuppression typically required for donor-derived (allogeneic) cell products.

Conclusion

RMAT designation doesn’t guarantee approval, and sasineprocel remains an investigational therapy years from potential availability. But with Phase III testing expected to begin later this year, this is a program worth tracking closely as it moves from early safety signals toward controlled efficacy data.

Sources

  • BioSpace / PRNewswire, “Aspen Neuroscience Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Sasineprocel (ANPD001) to Treat Parkinson’s Disease” — Read here
  • NeurologyLive, “FDA Grants RMAT Designation to Sasineprocel for Parkinson Disease” — Read here
  • AllSci, “FDA grants Aspen RMAT designation for cell therapy in Parkinson’s disease” — Read here

FDA Grants RMAT Status to Allocetra, a Cell Therapy for Knee Osteoarthritis

FDA Grants RMAT Status to Allocetra, a Cell Therapy for Knee Osteoarthritis

The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Allocetra, an investigational cell therapy from Enlivex, for age-related symptomatic knee osteoarthritis in adults 64 and older. The designation is based on six-month data showing durable improvements in pain and function.

What Happened

The FDA has granted Regenerative Medicine Advanced Therapy designation to Allocetra, Enlivex’s clinical-stage cell therapy, for the treatment of age-related symptomatic knee osteoarthritis in patients aged 64 and older. RMAT designation, created under the 21st Century Cures Act, is reserved for cell and gene therapies that show potential to treat, modify, reverse, or cure a condition with significant unmet need, combining the benefits of fast track and breakthrough therapy designations, including intensive early FDA engagement and potential eligibility for accelerated approval and priority review.

Enlivex CEO Oren Hershkovitz said the designation reflects the strength of the company’s clinical data and its decision to concentrate development on the age group that showed the strongest response in its Phase I/IIa trial.

How Allocetra Works

Allocetra is an allogeneic, off-the-shelf cell therapy composed of donor-derived apoptotic cells. Rather than replacing damaged joint tissue directly, it works by reprogramming macrophages — immune cells that drive chronic joint inflammation — back into a homeostatic state. That approach targets inflammation at its source rather than simply managing symptoms, distinguishing it from existing osteoarthritis treatments, none of which are FDA- or EMA-approved to slow or reverse structural joint damage.

A similar rationale supported RMAT designation for Genascence’s GNSC-001, a gene therapy for knee osteoarthritis, roughly a year earlier in July 2025 — suggesting regulators are increasingly receptive to therapies aimed at OA’s underlying inflammatory drivers rather than pain control alone.

What the Data Show

Three-month data reported in August 2025 showed that in patients 60 and older, Allocetra produced substantial reductions in pain and improvements in function compared with placebo, with the effect size correlating positively with age. Six-month follow-up data, reported in November 2025, confirmed the effect held: on a composite pain-and-function endpoint, patients 61 and older receiving Allocetra improved by 27.8 points versus 15.5 points in the placebo group — an 80% improvement over placebo (p=0.02).

Enlivex is now enrolling a global, multicenter, randomized, double-blind, placebo-controlled Phase IIb trial in the same age-related OA population, with active sites in the US, Denmark, and Poland.

Why This Matters

For practitioners and patients in regenerative and integrative medicine, this designation is a signal worth tracking. Knee osteoarthritis is one of the most common reasons patients seek non-surgical regenerative options — PRP, prolotherapy, and related injection therapies — precisely because standard treatments only manage pain rather than address the underlying joint inflammation. A therapy designed to reprogram immune signaling rather than mask symptoms represents a meaningful shift in how the condition could eventually be approached in mainstream care, and RMAT status means the FDA pathway toward approval could move faster than the standard track. It’s still investigational and years from being available to patients, but it reinforces that immune modulation — not just tissue replacement — is becoming a serious avenue in regenerative orthopedics.

Conclusion

Allocetra’s RMAT designation doesn’t change treatment options today, but it marks another concrete step for immune-based regenerative therapies moving through FDA review. With Phase IIb enrollment underway at US sites, this is a story worth revisiting as new data emerges.

Sources

  • BioPharm International, “Enlivex’s Allocetra Wins FDA RMAT Designation for Age-Related Knee Osteoarthritis” — Read here
  • BioPharm International, “The BioPharm Brief: Regeneration, Responses, and Regulatory Wins” — Read here
941-444-6336 Directions