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
Creative Medical Technology Holdings (NASDAQ: CELZ) has reported positive initial data from the first cohort of its Phase 1/2 clinical trial of CELZ-201-DDT, a stem cell-based treatment for chronic back pain caused by degenerative disc disease (DDD). The first cohort, consisting of 8 treated patients and 2 placebo recipients, completed the study phase successfully with no dose-limiting toxicities or serious adverse events.
The blinded preliminary data indicates promising therapeutic potential in pain relief and functionality improvement. The independent Data Safety Monitoring Board (DSMB) has recommended proceeding to the next cohort as planned. Enrollment for the second cohort is expected in Q1 2025.
Creative Medical Technology Holdings (NASDAQ: CELZ) ha riportato dati positivi iniziali dal primo gruppo del suo trial clinico di fase 1/2 su CELZ-201-DDT, un trattamento a base di cellule staminali per il dolore cronico alla schiena causato da malattia del disco degenerativa (DDD). Il primo gruppo, composto da 8 pazienti trattati e 2 riceventi placebo, ha completato con successo la fase dello studio senza tossicità limitanti la dose o eventi avversi gravi.
I dati preliminari in cieco indicano un promettente potenziale terapeutico nel sollievo dal dolore e nel miglioramento della funzionalità. Il Comitato Indipendente di Monitoraggio della Sicurezza dei Dati (DSMB) ha raccomandato di procedere al prossimo gruppo come previsto. L'arruolamento per il secondo gruppo è previsto nel primo trimestre del 2025.
Creative Medical Technology Holdings (NASDAQ: CELZ) ha informado sobre datos iniciales positivos del primer grupo de su ensayo clínico de fase 1/2 de CELZ-201-DDT, un tratamiento basado en células madre para el dolor de espalda crónico causado por la enfermedad degenerativa del disco (DDD). El primer grupo, que consta de 8 pacientes tratados y 2 receptores de placebo, completó la fase del estudio con éxito sin toxicidades limitantes de dosis ni eventos adversos graves.
Los datos preliminares enmascarados indican un prometedor potencial terapéutico en el alivio del dolor y la mejora de la funcionalidad. La Junta Independiente de Monitoreo de Seguridad de Datos (DSMB) ha recomendado avanzar al siguiente grupo según lo planeado. Se espera que el reclutamiento para el segundo grupo comience en el primer trimestre de 2025.
크리에이티브 메디컬 테크놀로지 홀딩스 (NASDAQ: CELZ)는 CELZ-201-DDT의 1상/2상 임상 시험 첫 번째 군에서 긍정적인 초기 데이터를 보고했습니다. 이 치료는 퇴행성 디스크 질환 (DDD)으로 인한 만성 요통에 대한 줄기 세포 기반 치료입니다. 첫 번째 군은 치료를 받은 8명의 환자와 2명의 위약 수령자로 구성되어 있으며, 용량 제한 독성이나 심각한 부작용 없이 연구 단계를 성공적으로 완료했습니다.
맹검된 초기 데이터는 통증 완화 및 기능 개선 측면에서 유망한 치료 가능성을 나타냅니다. 독립 데이터 안전성 모니터링 위원회(DSMB)는 계획대로 다음 군으로 진행할 것을 권장했습니다. 두 번째 군의 모집은 2025년 1분기에 예상됩니다.
Creative Medical Technology Holdings (NASDAQ: CELZ) a rapporté des données initiales positives de la première cohorte de son essai clinique de phase 1/2 sur CELZ-201-DDT, un traitement basé sur des cellules souches pour la douleur chronique au dos causée par la maladie dégénérative du disque (DDD). La première cohorte, composée de 8 patients traités et de 2 receveurs de placebo, a réussi à compléter la phase de l'étude sans toxicités limitantes par la dose ni événements indésirables graves.
Les données préliminaires en aveugle indiquent un potentiel thérapeutique prometteur pour le soulagement de la douleur et l'amélioration de la fonctionnalité. Le Comité Indépendant de Surveillance de la Sécurité des Données (DSMB) a recommandé de procéder à la prochaine cohorte comme prévu. L'inscription pour la deuxième cohorte est attendue au premier trimestre 2025.
Creative Medical Technology Holdings (NASDAQ: CELZ) hat positive erste Daten aus der ersten Kohorte seiner Phase 1/2-Klinikstudie zu CELZ-201-DDT gemeldet, einer auf Stammzellen basierenden Behandlung von chronischen Rückenschmerzen, die durch degenerative Bandscheibenerkrankungen (DDD) verursacht werden. Die erste Kohorte, bestehend aus 8 behandelten Patienten und 2 Placeboempfängern, hat die Studienphase erfolgreich abgeschlossen, ohne dosisbegrenzende Toxizitäten oder schwere unerwünschte Ereignisse.
Die verblindeten vorläufigen Daten zeigen vielversprechendes therapeutisches Potenzial bei der Schmerzlinderung und Verbesserung der Funktionsfähigkeit. Die unabhängige Daten-Sicherheitsüberwachungskommission (DSMB) hat empfohlen, wie geplant mit der nächsten Kohorte fortzufahren. Die Rekrutierung für die zweite Kohorte wird für das erste Quartal 2025 erwartet.
- Successful completion of first cohort with no serious adverse events
- Positive preliminary efficacy signals in pain relief and functionality
- DSMB approval to proceed with next trial phase
- Development of non-opioid therapeutic option for chronic back pain
- Early-stage trial with patient data (only 10 participants)
- Blinded data only - full efficacy results not yet available
PHOENIX, Jan. 30, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a clinical-stage biotechnology company focused on regenerative medicine, today announced promising initial data from the first cohort of its ongoing Phase 1/2 clinical trial of CELZ-201-DDT, the Company’s proprietary stem cell-based therapeutic for the treatment of chronic back pain caused by degenerative disc disease (DDD).
The first cohort of 10 participants (8 receiving CELZ-201-DDT and 2 receiving placebo) completed the study phase without any dose-limiting toxicities or serious adverse events. Blinded preliminary data suggest encouraging therapeutic potential in alleviating back pain and restoring functionality. Following a comprehensive safety review, the independent Data Safety Monitoring Board (DSMB) recommended the trial proceed to the next cohort as planned.
Key Milestones Achieved:
- 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.
“This milestone underscores our commitment to addressing chronic back pain, a debilitating condition with limited effective treatment options,” said Timothy Warbington, President and CEO of Creative Medical Technology Holdings. “The safety and early signals observed in this trial strengthen our belief that CELZ-201-DDT has the potential to transform the standard of care for patients suffering from degenerative disc disease.”
Advancing Innovation in Regenerative Medicine
Creative Medical Technology Holdings is committed to pioneering regenerative solutions that improve quality of life for patients with chronic and debilitating conditions. CELZ-201-DDT represents the Company’s dedication to leveraging stem cell technology to address the root causes of pain and degenerative conditions, providing patients with a novel, non-opioid therapeutic option.
“Our progress with CELZ-201-DDT highlights our vision to deliver groundbreaking therapies for chronic conditions such as degenerative disc disease,” added Warbington. “We are eager to move forward with the trial and are optimistic about the therapy’s ability to provide long-lasting pain relief and improved functionality for patients.”
About CELZ-201-DDT
CELZ-201-DDT is a proprietary regenerative stem cell-based therapy designed to address chronic back pain caused by DDD. By targeting the underlying causes of DDD, CELZ-201-DDT has the potential to restore disc integrity and reduce pain, providing a novel therapeutic approach to a condition that affects millions of patients. Using an ultrasound guided, non-surgical procedure CELZ-201-DDT is injected in areas surrounding the diseased disc(s), thereby potentially repairing, remodeling, and improving the blood supply around the disc and lower back area, without exposing the patient to radiation as with other cell-based procedures.
The Phase 1 / 2 study is designed to evaluate the safety, efficacy, and tolerability of CELZ-201-DDT. The study will enroll 30 individuals suffering from chronic lower back pain.
About Creative Medical Technology Holdings
Creative Medical Technology Holdings, Inc. is a biotechnology company focused on developing regenerative and stem cell-based therapies for unmet medical needs. Leveraging its proprietary platforms, the Company is advancing a robust pipeline of innovative treatments to improve patient outcomes and revolutionize regenerative medicine. For more information, visit www.creativemedicaltechnology.com.
Forward-Looking Statements
This press release contains forward-looking statements under the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, including those detailed in the Company’s filings with the Securities and Exchange Commission. Forward-looking statements reflect the Company’s current views but are not guarantees of future results.
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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