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Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain

Study acronym: ADAPT
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later May 1, 2026 → Jan 20, 2027
See other at-risk trials from Creative Medical Technology Holdings Inc

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from May 1, 2026 to Jan 20, 2027
    • Enrollment closed, study ongoing
    • Study completion pushed from May 1, 2027 to Aug 20, 2027
    • Site details revised
    v9
  2. Enrollment target: 30 to 45v8 Show 5 more changesShow less
    • Primary completion date: Nov 1, 2025 to May 1, 2026
    • Study completion date: Oct 1, 2026 to May 1, 2027
    • Eligibility criteria expanded, about 28 words
    • Study description expanded, about 26 words
    • Study arms: 3 to 4
  3. Primary completion date: May 21, 2025 to Nov 1, 2025
    • Study completion date: May 21, 2026 to Oct 1, 2026
    • Eligibility criteria expanded, about 4 words
    v7
  4. Site contact updatedv6
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Apr 1, 2024 to May 21, 2024
    • Primary completion date: Apr 1, 2025 to May 21, 2025
    • Study completion date: Apr 1, 2026 to May 21, 2026
    • Study site revised
    v4
  2. Start date: Nov 1, 2023 to Apr 1, 2024
    • Primary completion date: Nov 1, 2024 to Apr 1, 2025
    • Study completion date: Nov 1, 2025 to Apr 1, 2026
    v3
  3. Study site revisedv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The brief purpose of this research study is to learn about the safety, tolerability, and efficacy of paraspinal intramuscular injection of CELZ-201-DDT in patients with chronic lower back pain.
Trial Details
NCT Number NCT06053242
Lead Sponsor Creative Medical Technology Holdings Inc
Conditions
(from sponsor)		 Chronic Low-back Pain, Degenerative Disc Disease
Related terms Intervertebral Disc Degeneration
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov