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

Part of paid clinical trials in Aventura, Florida.

Sponsor
Creative Medical Technology Holdings Inc
Study ID
NCT06053242
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • CELZ-201-DDT — DRUG
    Subjects enrolled in the trial will receive CELZ-201-DDT at the specified dose into the lumbar paraspinal musculature. Each subject will receive a total of six injections, three injections on each side, under direct ultrasound guidance.
  • Placebo — OTHER
    Subjects will receive a placbeo injection into the lumbar paraspinal musculature. Each subject will receive a total of six injections, three injections on each side, under direct ultrasound guidance.

Study Details

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.

Key Dates

Start date
May 21, 2024
Status verified
Feb 2026
Primary completion
May 1, 2026
Completion
May 1, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low Dose
    Subjects in the low dose arm will receive a single administration of either 6x10\^6 cells (n=8) or a placebo injection (n=2). Each subject will receive six paraspinal intramuscular injections (three injections per side) of either CELZ-201-DDT or placebo into the lumbar musculature under direct ultrasound guidance.
  • Experimental: Medium Dose
    Subjects in the medium dose arm will receive a single administration of either 30x10\^6 cells (n=8) or a placebo injection (n=2). Each subject will receive six paraspinal intramuscular injections (three injections per side) of either CELZ-201-DDT or placebo into the lumbar musculature under direct ultrasound guidance.
  • Experimental: High Dose
    Subjects in the high dose arm will receive a single administration of either 60x10\^6 cells (n=8) or a placebo injection (n=2). Each subject will receive six paraspinal intramuscular injections (three injections per side) of either CELZ-201-DDT or placebo into the lumbar musculature under direct ultrasound guidance.
  • Experimental: Expanded High Dose
    Subjects in the expanded high dose arm will receive a single administration of either 120x10\^6 cells (n=10) or a placebo injection (n=5). Each subject will receive six paraspinal intramuscular injections (three injections per side) of either CELZ-201-DDT or placebo into the lumbar musculature under direct ultrasound guidance.

Primary Outcome Measure

Evaluate safety of CELZ-201-DDT administered as intramuscular injections in subjects experiencing chronic lower back pain at a low, medium, or high dose. [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Spine and Wellness Centers of AmericaAventuraFlorida33180
Christian Gonzalez, MD
(305) 974-5533
Christian Gonzalez, MD (PRINCIPAL_INVESTIGATOR)
Gina Corsaletti, MD (SUB_INVESTIGATOR)

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By research site
Spine and Wellness Centers of America· Aventura, FL

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