AlloStem (CELZ-201) / Creative Medical Technology - LARVOL DELTA

Creative Medical Technology Holdings Secures FDA Clearance for Expanded Dose Escalation in the Clinical Trial of CELZ-201-DDT for Chronic Lower Back Pain (GlobeNewswire) - "Creative Medical Technology Holdings, Inc...today announced that the U.S. Food and Drug Administration (FDA) has cleared an expanded dose escalation for its ongoing Phase 1/2 trial of StemSpine using AlloStem (CELZ-201-DDT), the Company’s proprietary allogeneic (donor) cell therapy for chronic lower back pain caused by degenerative disc disease (DDD). This regulatory milestone follows compelling interim blinded data demonstrating statistically significant pain reduction and improved mobility among trial participants."

FDA event • Back Pain

Creative Medical Technology Reports Positive One-Year Results for AlloStem Type 2 Diabetes Program (GlobeNewswire) - P=NA | N=20 | "Creative Medical Technology Holdings, Inc...today announced promising one-year follow-up data from the AlloStem (CELZ-201) Type 2 Diabetes pilot study for late-stage patients....Results demonstrate that CELZ-201 achieved an 80% overall efficacy rate in reducing insulin dependency and stabilizing hemoglobin A1c levels, with no serious adverse effects reported....The absence of safety concerns further supports the potential of CELZ-201 as a breakthrough treatment for late-stage Type 2 Diabetes....Given these compelling results, Creative Medical Technology plans to advance the development of AlloStem (CELZ-201) for the treatment of late-stage Type 2 Diabetes and explore other potential applications of this therapy to expand the Company’s pipeline."

Clinical data • Type 2 Diabetes Mellitus

Creative Medical Technology Holdings Announces Positive Initial Safety, Tolerability, and Efficacy Data from First Cohort in Phase 1/2 Trial of CELZ-201-DDT for Chronic Back Pain (GlobeNewswire) - P1/2 | N=30 | ADAPT (NCT06053242) | "Safety Confirmed: CELZ-201-DDT demonstrated an excellent safety profile, with no serious adverse events reported in the first cohort; Preliminary Efficacy Signals: Blinded data suggest potential therapeutic benefit in addressing chronic back pain associated with degenerative disc disease; DSMB Endorsement: The DSMB approved continuation of the study, validating the safety and integrity of the trial design; Next Steps: Enrollment for the second cohort is expected in the current first quarter of 2025, with comprehensive data from subsequent cohorts guiding future clinical and regulatory plans."

DSMB • P1/2 data • Trial status • Back Pain • Pain

ADAPT: Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Creative Medical Technology Holdings Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Back Pain • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

ADAPT: Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: Creative Medical Technology Holdings Inc | Trial completion date: Nov 2025 ➔ Apr 2026 | Initiation date: Nov 2023 ➔ Apr 2024 | Trial primary completion date: Nov 2024 ➔ Apr 2025

Trial completion date • Trial initiation date • Trial primary completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Creative Medical Technology Holdings Announces IRB Approval for FDA Cleared Phase 1/2 Clinical Trial of StemSpine using AlloStem™ ("CELZ-201-DDT") Novel Cell Therapy to Treat Chronic Lower Back Pain (PRNewswire) - "Creative Medical Technology Holdings, Inc...today announced that it has received Institutional Review Board ('IRB') approval to proceed with its clinical trial for the treatment of chronic lower back pain with its StemSpine® procedure using AlloStem (CELZ-201-DDT) cell therapy. The receipt of IRB approval is a necessary step that will allow Creative Medical Technology to move forward with recruitment of its recently FDA approved Phase 1 /2 randomized, double blind, placebo controlled clinical trial to evaluate the safety, efficacy, and tolerability of CELZ-201-DDT. The study will enroll 30 individuals suffering from chronic lower back pain caused by Degenerative Disc Disease."

Trial status • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

ADAPT: Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: Creative Medical Technology Holdings Inc

New P1/2 trial • Back Pain • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

CREATE-1: Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes (clinicaltrials.gov) - P1/2 | N=18 | Recruiting | Sponsor: Creative Medical Technology Holdings Inc | Active, not recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Creative Medical Technology Holdings Announces IRB Approval for FDA Cleared Phase 1/2 Clinical Trial of Novel Cell Therapy for the Treatment of Type 1 Diabetes (PRNewswire) - "Creative Medical Technology Holdings...today announced that it has received Institutional Review Board (IRB) approval to proceed with its Clinical Trial for the treatment of Type 1 Diabetes with its CELZ-201 cell therapy....'We are pleased with achieving IRB approval expeditiously and look forward to moving forward with our Phase 1/2 clinical trial,'..."

New P2/3 trial • Diabetes • Type 1 Diabetes Mellitus

CREATE-1: Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes (clinicaltrials.gov) - P1/2 | N=18 | Active, not recruiting | Sponsor: Creative Medical Technology Holdings Inc | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

CREATE-1: Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes (clinicaltrials.gov) - P1/2 | N=18 | Not yet recruiting | Sponsor: Creative Medical Technology Holdings Inc

New P1/2 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus