Creative Medical Technology Holdings Announces Mid-Term Follow-up Study Data Reporting Significant Reduction in Opioid Use by Chronic Lower Back Pain Patients Undergoing StemSpine® Procedure using AlloStem™

Rhea-AI Summary

Creative Medical Technology Holdings (NASDAQ: CELZ) has released mid-term follow-up data from its StemSpine® pilot study using AlloStem™ cells for chronic lower back pain treatment. The study showed remarkable results with over 90% of patients reporting no opioid use three years after the procedure, alongside an 80% reduction in pain scores and over 60% improvement in Oswestry Disability Index scores.

StemSpine® is a non-surgical, ultrasound-guided procedure utilizing AlloStem™, an 'off-the-shelf' donor-derived cell therapy. The procedure demonstrated strong safety with only one patient requiring reintervention at the three-year mark and no serious adverse events reported. The company is currently conducting an FDA-cleared Phase 1/2 ADAPT clinical trial, which is seeing strong enrollment driven by these positive pilot study results.

Positive

• 90% of patients eliminated opioid use after three years
• 80% reduction in pain scores maintained
• 60% improvement in Oswestry Disability Index scores
• Strong safety profile with no serious adverse events
• FDA-cleared Phase 1/2 trial showing strong enrollment

Negative

• One patient required reintervention after three years

Study Demonstrates Robust Efficacy and Strong Safety Profile

PHOENIX, Feb. 14, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. ("Creative Medical Technology" or the "Company") (NASDAQ: CELZ), a pioneering biotechnology firm specializing in regenerative medicine solutions for immunotherapy, endocrinology, urology, gynecology, and orthopedics, today announced compelling mid-term follow-up data from its StemSpine^® pilot study utilizing its AlloStem™ cells for the treatment of chronic lower back pain.

The pilot study demonstrated a substantial reduction in opioid dependency and significant improvements in pain levels and functional mobility. Notably, over 90% of patients reported no opioid use for pain management three years post-procedure, with an 80% persistent reduction in pain scores and a greater than 60% improvement in Oswestry Disability Index scores. Only one patient required reintervention at the three-year follow-up mark, and no serious adverse events were reported, reinforcing the favorable safety profile of the StemSpine® procedure.

StemSpine® is a proprietary, patented, non-surgical, ultrasound-guided procedure that leverages AlloStem™, an "off-the-shelf" allogenic (donor-derived) cell therapy developed by the Company. The StemSpine^® patent encompasses the use of both autologous (patient-derived) and allogenic cells, broadening its clinical utility.

"Opioid dependency remains a pressing concern for individuals suffering from chronic lower back pain," said Timothy Warbington, President and CEO of Creative Medical Technology Holdings. "These results underscore the safety and clinical efficacy of AlloStem™ in the StemSpine^® procedure by promoting repair, remodeling, and improved vascularization in the affected areas. This promising data supports our vision of providing innovative, non-surgical solutions for millions of Americans struggling with chronic lower back pain.”

The StemSpine pilot study data is independent of the Company’s ongoing FDA-cleared Phase 1/2 ADAPT clinical trial of CELZ-201-DDT for chronic lower back pain; however, these compelling findings continue to drive strong enrollment in the prospective, randomized, double-blind, dose-escalation ADAPT study, further reinforcing StemSpine^® as a groundbreaking advancement in regenerative medicine.  

Study Details | Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain | ClinicalTrials.gov

About Creative Medical Technology Holdings, Inc.
Creative Medical Technology Holdings, Inc. is a biotechnology company dedicated to the advancement of identifying and translating novel biological therapeutics in the fields of immunotherapy, endocrinology, urology, gynecology, and orthopedics and is traded on NASDAQ under the ticker symbol CELZ. For further information about the Company, please visit www.creativemedicaltechnology.com.

Forward Looking Statements
This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website at www.sec.gov.

Contact:
Creative Medical Technology Holdings, Inc.
IR@CreativeMedicalTechnology.com

Investor Relations:
Devin Sullivan, Managing Director
The Equity Group Inc.
dsullivan@equityny.com

FAQ

What are the success rates of CELZ's StemSpine treatment for chronic back pain?

The StemSpine treatment showed over 90% success rate in eliminating opioid use after three years, with 80% reduction in pain scores and over 60% improvement in Oswestry Disability Index scores.

How safe is CELZ's StemSpine procedure based on the latest study?

The study demonstrated a strong safety profile with no serious adverse events reported, and only one patient requiring reintervention after three years.

What is the current stage of CELZ's StemSpine clinical development?

CELZ is currently conducting an FDA-cleared Phase 1/2 ADAPT clinical trial, with the pilot study results driving strong enrollment.

How effective is CELZ's StemSpine in reducing opioid dependency?

According to the mid-term follow-up data, over 90% of patients reported no opioid use for pain management three years after the StemSpine procedure.

What type of cells does CELZ use in the StemSpine procedure?

StemSpine uses AlloStem™, an 'off-the-shelf' allogenic (donor-derived) cell therapy, and the patent covers both autologous (patient-derived) and allogenic cells.