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™
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.
Creative Medical Technology Holdings (NASDAQ: CELZ) ha rilasciato dati di follow-up a medio termine dal suo studio pilota StemSpine® che utilizza cellule AlloStem™ per il trattamento del dolore cronico alla schiena. Lo studio ha mostrato risultati notevoli con oltre il 90% dei pazienti che ha riportato di non utilizzare oppioidi tre anni dopo la procedura, insieme a una riduzione dell'80% nei punteggi del dolore e a un oltre 60% di miglioramento nei punteggi dell'Oswestry Disability Index.
StemSpine® è una procedura non chirurgica, guidata da ultrasuoni, che utilizza AlloStem™, una terapia cellulare derivata da donatori 'pronta all'uso'. La procedura ha dimostrato una forte sicurezza, con solo un paziente che ha richiesto un intervento di riesame dopo tre anni e nessun evento avverso grave riportato. L'azienda sta attualmente conducendo uno studio clinico di Fase 1/2 ADAPT approvato dalla FDA, che sta vedendo un forte interesse grazie a questi risultati positivi dello studio pilota.
Creative Medical Technology Holdings (NASDAQ: CELZ) ha publicado datos de seguimiento a medio plazo de su estudio piloto StemSpine® que utiliza células AlloStem™ para el tratamiento del dolor lumbar crónico. El estudio mostró resultados notables con más del 90% de los pacientes reportando no usar opioides tres años después del procedimiento, junto con una reducción del 80% en los puntajes de dolor y una mejora de más del 60% en los puntajes del Índice de Discapacidad de Oswestry.
StemSpine® es un procedimiento no quirúrgico, guiado por ultrasonido, que utiliza AlloStem™, una terapia celular derivada de donantes 'lista para usar'. El procedimiento demostró una fuerte seguridad, con solo un paciente requiriendo reintervención en el marco de tres años y sin eventos adversos graves reportados. La empresa está llevando a cabo actualmente un ensayo clínico de Fase 1/2 ADAPT aprobado por la FDA, que está viendo una fuerte inscripción impulsada por estos resultados positivos del estudio piloto.
Creative Medical Technology Holdings (NASDAQ: CELZ)는 만성 요통 치료를 위한 AlloStem™ 세포를 사용한 StemSpine® 파일럿 연구의 중간 추적 데이터를 발표했습니다. 이 연구는 절차 후 3년이 지난 후 90% 이상의 환자가 오피오이드 사용을 보고하지 않았다는 주목할 만한 결과를 보여주었으며, 통증 점수가 80% 감소하고 Oswestry 장애 지수 점수가 60% 이상 개선되었습니다.
StemSpine®는 AlloStem™을 활용한 비수술적 초음파 유도 절차로, '즉시 사용 가능한' 기증자 유래 세포 치료법입니다. 이 절차는 3년 후 재개입이 필요한 환자가 단 한 명이었고 심각한 부작용이 보고되지 않아 안전성이 뛰어난 것으로 나타났습니다. 현재 이 회사는 FDA 승인을 받은 1/2상 ADAPT 임상 시험을 진행 중이며, 긍정적인 파일럿 연구 결과로 인해 강력한 등록을 보고하고 있습니다.
Creative Medical Technology Holdings (NASDAQ: CELZ) a publié des données de suivi à moyen terme de son étude pilote StemSpine® utilisant des cellules AlloStem™ pour le traitement de la douleur lombaire chronique. L'étude a montré des résultats remarquables, avec plus de 90 % des patients signalant ne pas avoir utilisé d'opioïdes trois ans après la procédure, ainsi qu'une réduction de 80 % des scores de douleur et une amélioration de plus de 60 % des scores de l'Indice de Disabilité d'Oswestry.
StemSpine® est une procédure non chirurgicale, guidée par ultrasons, utilisant AlloStem™, une thérapie cellulaire dérivée de donneurs 'prête à l'emploi'. La procédure a montré une grande sécurité, avec seulement un patient ayant nécessité une réintervention après trois ans et aucun événement indésirable grave signalé. L'entreprise mène actuellement un essai clinique de Phase 1/2 ADAPT approuvé par la FDA, qui connaît un fort taux d'inscription grâce à ces résultats positifs de l'étude pilote.
Creative Medical Technology Holdings (NASDAQ: CELZ) hat Zwischenergebnisse aus seiner StemSpine®-Pilotstudie veröffentlicht, die AlloStem™-Zellen zur Behandlung von chronischen Rückenschmerzen verwendet. Die Studie zeigte bemerkenswerte Ergebnisse, wobei über 90 % der Patienten angaben, drei Jahre nach dem Eingriff keine Opioide verwendet zu haben, verbunden mit einer 80 %igen Reduktion der Schmerzwerte und einer über 60 %igen Verbesserung der Oswestry Disability Index-Werte.
StemSpine® ist ein nicht-chirurgisches, ultraschallgeführtes Verfahren, das AlloStem™, eine 'regalverfügbare' zelltherapeutische Behandlung von Spendern, nutzt. Das Verfahren zeigte eine hohe Sicherheit, da nur ein Patient nach drei Jahren eine erneute Intervention benötigte und keine schwerwiegenden unerwünschten Ereignisse gemeldet wurden. Das Unternehmen führt derzeit eine von der FDA genehmigte Phase 1/2 ADAPT-Studie durch, die aufgrund dieser positiven Pilotstudienergebnisse eine hohe Einschreibung verzeichnet.
- 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
- 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
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.
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
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