Creative Medical Technology Holdings Secures FDA Clearance for Expanded Dose Escalation in the Clinical Trial of CELZ-201-DDT for Chronic Lower Back Pain
Creative Medical Technology Holdings (NASDAQ: CELZ) has received FDA clearance for expanded dose escalation in its Phase 1/2 trial of StemSpine® using AlloStem™ (CELZ-201-DDT), a cell therapy for chronic lower back pain caused by degenerative disc disease.
The trial's interim blinded data shows statistically significant pain reduction and improved mobility among participants. Key highlights include:
- No dose-limiting toxicities or serious adverse events reported at trial's halfway point
- Study employs minimally invasive ultrasound-guided injection with 4:1 treatment-to-placebo ratio
- Both Data Safety Monitoring Board (DSMB) and Institutional Review Board (IRB) have approved the new dosing strategy
The company reports enrollment remains on track, with final data expected to inform future clinical and regulatory strategies, potentially accelerating the pathway toward a pivotal Phase 3 trial for Biologics License Application (BLA) submission.
Creative Medical Technology Holdings (NASDAQ: CELZ) ha ricevuto l'approvazione della FDA per l'espansione dell'escalation della dose nel suo studio di Fase 1/2 di StemSpine® utilizzando AlloStem™ (CELZ-201-DDT), una terapia cellulare per il dolore cronico alla schiena inferiore causato da malattia degenerativa del disco.
I dati intermedi in cieco dello studio mostrano una riduzione del dolore statisticamente significativa e un miglioramento della mobilità tra i partecipanti. I punti salienti includono:
- Nessuna tossicità limitante la dose o eventi avversi gravi segnalati a metà dello studio
- Lo studio utilizza un'iniezione guidata da ultrasuoni minimamente invasiva con un rapporto trattamento-placebo di 4:1
- Sia il Data Safety Monitoring Board (DSMB) che l'Institutional Review Board (IRB) hanno approvato la nuova strategia di dosaggio
L'azienda riporta che l'arruolamento procede secondo i piani, con dati finali attesi per informare le future strategie cliniche e regolatorie, potenzialmente accelerando il percorso verso uno studio pivotale di Fase 3 per la presentazione della Biologics License Application (BLA).
Creative Medical Technology Holdings (NASDAQ: CELZ) ha recibido la aprobación de la FDA para la escalación de dosis ampliada en su ensayo de Fase 1/2 de StemSpine® utilizando AlloStem™ (CELZ-201-DDT), una terapia celular para el dolor crónico en la parte baja de la espalda causado por enfermedad degenerativa del disco.
Los datos interinos enmascarados del ensayo muestran una reducción del dolor estadísticamente significativa y una mejora en la movilidad entre los participantes. Los puntos destacados incluyen:
- No se reportaron toxicidades limitantes de dosis ni eventos adversos graves en la mitad del ensayo
- El estudio emplea inyección guiada por ultrasonido mínimamente invasiva con una relación de tratamiento a placebo de 4:1
- Tanto el Data Safety Monitoring Board (DSMB) como el Institutional Review Board (IRB) han aprobado la nueva estrategia de dosificación
La empresa informa que la inscripción sigue en camino, con datos finales esperados para informar futuras estrategias clínicas y regulatorias, potencialmente acelerando el camino hacia un ensayo pivotal de Fase 3 para la presentación de la Biologics License Application (BLA).
Creative Medical Technology Holdings (NASDAQ: CELZ)는 AlloStem™ (CELZ-201-DDT)를 사용한 StemSpine®의 1/2상 시험에서 용량 증가에 대한 FDA 승인을 받았습니다. 이는 퇴행성 디스크 질환으로 인한 만성 요통을 위한 세포 치료제입니다.
시험의 중간 블라인드 데이터는 참가자들 사이에서 통계적으로 유의미한 통증 감소와 이동성 향상을 보여줍니다. 주요 내용은 다음과 같습니다:
- 시험 중간 지점에서 용량 제한 독성 또는 심각한 부작용 보고 없음
- 연구는 4:1의 치료 대 위약 비율로 최소 침습 초음파 유도 주사를 사용합니다
- 데이터 안전 모니터링 위원회(DSMB)와 기관 검토 위원회(IRB)가 새로운 용량 전략을 승인했습니다
회사는 등록이 순조롭게 진행되고 있으며, 최종 데이터는 향후 임상 및 규제 전략을 알리는 데 기대되고 있으며, 이는 생물학적 제품 허가 신청(BLA)을 위한 중요한 3상 시험으로 가는 경로를 가속화할 수 있습니다.
Creative Medical Technology Holdings (NASDAQ: CELZ) a reçu l'approbation de la FDA pour une escalade de dose élargie dans son essai de Phase 1/2 de StemSpine® utilisant AlloStem™ (CELZ-201-DDT), une thérapie cellulaire pour la douleur chronique dans le bas du dos causée par une maladie dégénérative du disque.
Les données intermédiaires en aveugle de l'essai montrent une réduction statistiquement significative de la douleur et une amélioration de la mobilité parmi les participants. Les points clés incluent :
- Aucune toxicité limitant la dose ou événements indésirables graves signalés à mi-parcours de l'essai
- L'étude utilise une injection guidée par ultrasons minimement invasive avec un ratio traitement-placebo de 4:1
- Le Data Safety Monitoring Board (DSMB) et l'Institutional Review Board (IRB) ont approuvé la nouvelle stratégie de dosage
La société rapporte que l'inscription reste sur la bonne voie, avec des données finales attendues pour informer les futures stratégies cliniques et réglementaires, ce qui pourrait accélérer le chemin vers un essai pivot de Phase 3 pour la soumission d'une Biologics License Application (BLA).
Creative Medical Technology Holdings (NASDAQ: CELZ) hat die FDA-Zulassung für eine erweiterte Dosiserhöhung in seiner Phase 1/2-Studie von StemSpine® mit AlloStem™ (CELZ-201-DDT) erhalten, einer Zelltherapie gegen chronische Rückenschmerzen aufgrund degenerativer Bandscheibenerkrankungen.
Die vorläufigen verblindeten Daten der Studie zeigen eine statistisch signifikante Schmerzlinderung und verbesserte Mobilität bei den Teilnehmern. Zu den wichtigsten Punkten gehören:
- Keine dosislimitierenden Toxizitäten oder schwerwiegenden unerwünschten Ereignisse zum Zeitpunkt der Halbzeit der Studie berichtet
- Die Studie verwendet eine minimal-invasive, ultraschallgeführte Injektion mit einem Verhältnis von 4:1 zwischen Behandlung und Placebo
- Sowohl das Data Safety Monitoring Board (DSMB) als auch das Institutional Review Board (IRB) haben die neue Dosierungsstrategie genehmigt
Das Unternehmen berichtet, dass die Einschreibung planmäßig verläuft, wobei die endgültigen Daten voraussichtlich zukünftige klinische und regulatorische Strategien informieren werden, was den Weg zu einer entscheidenden Phase-3-Studie für die Einreichung eines Biologics License Application (BLA) beschleunigen könnte.
- Positive interim data showing statistically significant pain reduction and mobility improvement
- Strong safety profile with no serious adverse events reported
- FDA clearance for expanded dose escalation obtained
- Trial progressing on schedule toward potential Phase 3 study
- Trial still in early Phase 1/2 stage, far from potential commercialization
- Final efficacy data not yet available
Positive Interim Blinded Data Supports Advancement Toward Potential Pivotal Phase 3 Study
PHOENIX, March 20, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) (the “Company”), a clinical-stage biotechnology company specializing in regenerative medicine, 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.
The first-of-its-kind study employs a minimally invasive ultrasound-guided injection of CELZ-201-DDT in an outpatient setting, with a 4:1 treatment-to-placebo ratio. With half of the trial now completed, the study has reported no dose-limiting toxicities or serious adverse events, reinforcing both the safety and potential efficacy of the therapy. The FDA’s authorization allows the Company to expand dosing, further optimizing therapeutic outcomes. The Data Safety Monitoring Board (DSMB) and the Institutional Review Board (IRB) have already approved the new dosing strategy and it has been implemented.
Key Trial Milestones:
- Strong Safety Profile: No serious adverse events reported in the first half of the study.
- Encouraging Efficacy Signals: Blinded interim data demonstrates meaningful pain relief and improved mobility compared to baseline.
- Regulatory Green Light for Dose Expansion: FDA clearance secured to enhance treatment optimization.
- Continued Trial Momentum: Enrollment remains on track, with final data expected to shape future clinical and regulatory strategies.
“These promising findings continue to validate CELZ-201-DDT as a potential breakthrough, non-opioid therapy for chronic back pain,” said Timothy Warbington, President and CEO of Creative Medical Technology Holdings. “The FDA’s clearance of our expanded dosing strategy represents a significant step forward as we refine our approach to maximizing both safety and efficacy. If this positive data trend continues, we believe this could accelerate our pathway toward a pivotal Phase 3 trial for potential Biologics License Application (BLA) submission with the FDA.”
With a commitment to advancing regenerative medicine solutions, Creative Medical Technology Holdings remains focused on delivering innovative therapies that address critical unmet needs in pain management and tissue regeneration.
About CELZ-201-DDT
CELZ-201-DDT is a proprietary allogeneic regenerative therapy designed to target the underlying pathology of DDD. Administered via ultrasound-guided injection, it offers a minimally invasive, non-surgical approach aimed at reducing pain, restoring functionality, and enhancing tissue health without exposing the patient to radiation as with other cell-based therapies.
About Creative Medical Technology Holdings
Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) is a clinical-stage biotechnology company pioneering regenerative medicine solutions for multiple indications, including pain management, neurology, and urology. The company leverages cutting-edge cell therapy technologies to develop transformative treatments aimed at improving patient outcomes.
For more information, 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
Conor Rodriguez
Associate
crodriguez@equityny.com
FAQ
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