Creative Medical Technology Holdings, Inc. Advances FDA Cleared ADAPT Clinical Trial with Positive Independent Review, Validating the Safety and Potential of CELZ-201 for Chronic Lower Back Pain Treatment
Creative Medical Technology Holdings announced a successful independent interim safety review by the Data Safety Monitoring Board (DSMB) for its ADAPT clinical trial of CELZ-201, a perinatal tissue derived cell product for chronic lower back pain treatment. The DSMB reviewed safety data from the first five dosed patients and approved trial continuation, following a 30-day dose-limiting toxicity assessment. The ADAPT trial is a double-blind, randomized, placebo-controlled, dose-escalation study evaluating CELZ-201's safety and efficacy when administered intramuscularly. The treatment targets approximately 16 million US patients suffering from chronic lower back pain associated with degenerative disc disease.
Creative Medical Technology Holdings ha annunciato un'indipendente e positiva revisione intermedia della sicurezza da parte del Data Safety Monitoring Board (DSMB) per il suo studio clinico ADAPT relativo a CELZ-201, un prodotto cellulare derivato da tessuti perinatali per il trattamento del dolore cronico alla parte bassa della schiena. Il DSMB ha esaminato i dati di sicurezza dei primi cinque pazienti trattati e ha approvato la continuazione dello studio, dopo una valutazione della tossicità dose-limiting di 30 giorni. Lo studio ADAPT è un studio randomizzato, in doppio cieco, controllato con placebo e con aumento delle dosi che valuta la sicurezza e l'efficacia di CELZ-201 quando somministrato per via intramuscolare. Il trattamento è destinato a circa 16 milioni di pazienti statunitensi che soffrono di dolore cronico alla parte bassa della schiena associato a malattia degenerativa del disco.
Creative Medical Technology Holdings anunció una revisión intermedia independiente y exitosa de seguridad por parte del Data Safety Monitoring Board (DSMB) para su ensayo clínico ADAPT de CELZ-201, un producto celular derivado de tejido perinatal para el tratamiento del dolor crónico en la parte baja de la espalda. El DSMB revisó los datos de seguridad de los primeros cinco pacientes tratados y aprobó la continuación del ensayo, tras una evaluación de toxicidad por dosis de 30 días. El ensayo ADAPT es un estudio doble ciego, aleatorizado, controlado con placebo y de escalación de dosis que evalúa la seguridad y eficacia de CELZ-201 cuando se administra por vía intramuscular. El tratamiento está dirigido a aproximadamente 16 millones de pacientes en EE. UU. que sufren de dolor crónico en la parte baja de la espalda asociado con enfermedad degenerativa del disco.
Creative Medical Technology Holdings는 만성 요통 치료를 위한 CELZ-201의 ADAPT 임상 시험에 대해 데이터 안전성 모니터링 위원회(DSMB)가 성공적으로 독립적인 중간 안전성 검토를 수행했다고 발표했습니다. DSMB는 첫 다섯 명의 투약 환자로부터 안전성 데이터를 검토하고 30일 간의 용량 제한 독성 평가 이후 시험의 지속을 승인했습니다. ADAPT 시험은 이중 맹검, 무작위, 위약 대조, 용량 Escalation 연구로, CELZ-201의 안전성과 효과를 근육 내 주사로 평가합니다. 이 치료는 퇴행성 디스크 질환으로 인한 만성 요통을 앓고 있는 약 1,600만 미국 환자를 대상으로 합니다.
Creative Medical Technology Holdings a annoncé une revue intermédiaire de sécurité indépendante réussie par le Data Safety Monitoring Board (DSMB) pour son essai clinique ADAPT de CELZ-201, un produit cellulaire dérivé de tissus périnatals pour le traitement de la douleur chronique dans le bas du dos. Le DSMB a examiné les données de sécurité des cinq premiers patients traités et a approuvé la poursuite de l’essai, après une évaluation de toxicité par dose de 30 jours. L'essai ADAPT est une étude randomisée, en double aveugle, contrôlée par placebo et à escalade de doses qui évalue la sécurité et l'efficacité du CELZ-201 lorsqu'il est administré par voie intramusculaire. Le traitement cible environ 16 millions de patients américains souffrant de douleurs chroniques dans le bas du dos associées à une maladie dégénérative du disque.
Creative Medical Technology Holdings hat eine erfolgreiche unabhängige Zwischenbewertung der Sicherheit durch das Data Safety Monitoring Board (DSMB) für seine ADAPT-Studie zu CELZ-201 angekündigt, einem aus perinatalem Gewebe abgeleiteten Zellprodukt zur Behandlung von chronischen Rückenschmerzen. Das DSMB prüfte die Sicherheitsdaten der ersten fünf behandelten Patienten und genehmigte die Fortsetzung der Studie nach einer 30-tägigen Bewertung der dosislimitierenden Toxizität. Die ADAPT-Studie ist eine doppelblinde, randomisierte, placebo-kontrollierte, dosissteigernde Studie, die die Sicherheit und Wirksamkeit von CELZ-201 bei intramuskulärer Verabreichung bewertet. Die Behandlung zielt auf etwa 16 Millionen US-Patienten ab, die unter chronischen Rückenschmerzen durch degenerative Bandscheibenerkrankungen leiden.
- DSMB approved continuation of ADAPT clinical trial after safety review
- Successfully completed 30-day dose-limiting toxicity assessment for first five patients
- Treatment addresses large market of 16 million US patients with chronic lower back pain
- None.
PHOENIX, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a biotechnology leader in regenerative medicine, is pleased to announce the successful completion of an independent interim safety review by the Data Safety Monitoring Board (DSMB) for its ADAPT clinical trial. The trial evaluated CELZ-201, a novel therapeutic perinatal tissue derived cell product, designed to treat chronic lower back pain associated with degenerative disc disease.
The DSMB reviewed safety data from the first five dosed patients concluding that the trial may proceed as planned, underscoring the safety profile of CELZ-201 and supporting the advancement of this innovative therapy. This positive review follows the completion of a rigorous 30-day dose-limiting toxicity (DLT) assessment per patient, an important milestone as CELZ-201 moves closer to potentially transformative therapeutic outcomes for patients.
“The DSMB’s positive review marks an exciting and validating moment for Creative Medical Technology,” commented Timothy Warbington, CEO of Creative Medical Technology Holdings, Inc. “As we push forward and accelerate enrollment, the ADAPT trial continues to demonstrate not only the commitment of our team but also the potential of CELZ-201 to significantly address chronic lower back pain—a condition with limited long-term solutions for 16 million patients in the United States. This validation fuels our confidence in the safety and viability of our regenerative biologic approach, and we look forward to advancing towards the next stages of clinical development.”
The ADAPT trial (CELZ-201-ADAPT-2023) is a double-blind, randomized, placebo-controlled, dose-escalation study designed to rigorously evaluate the safety, tolerability, and efficacy of CELZ-201 administered intramuscularly using minimally invasive ultrasound techniques. The trial employs careful, protocol-driven monitoring of adverse events in alignment with Common Terminology Criteria for Adverse Events (CTCAE v.5), safeguarding patients and providing real-time data for DSMB review and study continuity. Regular DSMB reviews are scheduled to ensure ongoing compliance with safety standards, reinforcing CELZ-201’s clinical potential.
Creative Medical Technology Holdings continues to pursue cutting-edge therapies within its regenerative medicine and immunotherapy pipeline, pioneering safe, effective treatments for high-need indications. CELZ-201 exemplifies the company’s mission to develop targeted cellular therapies, combining rigorous science with strategic clinical insights to tackle previously unmet medical needs.
About Creative Medical Technology Holdings, Inc. Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) is a clinical-stage biotechnology company pioneering regenerative medicine therapies derived from adult stem cells. With a robust therapeutic platform, the Company is at the forefront of innovative solutions for degenerative diseases, committed to delivering transformative treatments for patients. Creative Medical Technology Holdings is dedicated to translating its scientific advancements into accessible, impactful care.
For more information, visit www.creativemedicaltechnology.com.
Forward-Looking Statements
This press release contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Statements may include predictions, forecasts, or indications of future results and are based on information available as of the date hereof. Forward-looking statements are subject to risks and uncertainties, including those detailed in Creative Medical Technology Holdings' filings with the Securities and Exchange Commission.
| Company Contact Creative Medical Technology IR@CreativeMedicalTechnology.com | Investor Relations Devin Sullivan, Managing Director The Equity Group Inc. dsullivan@equityny.com Conor Rodriguez, Analyst crodriguez@equityny.com |
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