Who is eligible for clinical trial NCT06053242?

Participants must meet the protocol's inclusion criteria for Chronic Low-back Pain. The stated age range is 18 Years to 80 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06053242 provide travel or cost reimbursement?

The protocol indicates compensation for participation. See the verified compensation note below. Confirm stipend details with the site coordinator.

🏛️ Verified NIH Record • Updated 2026-08-20

Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain (NCT06053242)

A Double-blinded, Randomized, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Effectiveness of CELZ-201-DDT Administered by Intramuscular Injection for the Treatment of Chronic Lower Back Pain in Patients With Degenerative Disc Disease

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Creative Medical Technology Holdings Inc

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (18 items).

Location: Spine and Wellness Centers of America — Aventura, Florida

Age range: 18 Years to 80 Years

🧪 Interventions in This Study

CELZ-201-DDT (DRUG)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Ability of participant to understand and the willingness to sign a written informed consent document.
Between 18-80 years of age and may be of either gender or any race.
Subjects must have failed at least two standard of care (SOC) therapies before being enrolled in the study: 1) exercise/physical therapy; 2) oral analgesic including nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen; 3) skeletal muscle relaxants. Subjects must have tried each SOC therapy for at least 3 months before failure is determined.
Patients must have failed the SOC therapies within 12 months of enrollment in the clinical trial.
Proof for one of the following tests already performed in the clinical care of the patient for lower back pain: 1) MRI scan demonstrating at least one disc level with grade II or greater disc degeneration using the Pfirrmann grading system; 2) Oswestry Disability Index for Back Pain score of 21-80%; 3) Visual Analogue Scale for pain of \>5 on a scale of 0-10.
Female subjects must not be breast feeding and must have no intention to become pregnant during the study, and she is using contraceptive drugs or devices.
Any male subject must agree to use contraceptives and not donate sperm during the study.
Subjects may be on stable opioids, narcotics, or muscle relaxants for ≥30 days before screening.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
History of cancer in the last five years.
Spinal infections and spinal tumors.
Renal insufficiency requiring dialysis or an eGFR of less than 60 mL/min/1.73m2.
ALT, AST greater than 2 times or Total Bilirubin 1.5 times the upper limit of the normal range.
Positive pregnancy test.
History of blood cell diseases.
Uncontrolled diabetes mellitus - HgA1c \>8%.
Uncontrolled hypertension defined as a systolic blood pressure of \>140 mmHg or diastolic blood pressure of \>90 mmHg at the time of screening. If subjects have their hypertension appropriately treated, then they would be eligible to enroll.
Patients known to have any active infection, including infection of the injection site(s), and/or any active systemic or local infection.
Patients on chronic immunosuppressive transplant therapy. Patients receiving \<5 mg of Prednisone daily may be included.
Subjects having a concomitant life-threatening disease in which their life expectancy is estimated to be less than 2 years.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Spine and Wellness Centers of America — Aventura, Florida

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
💵 Compensation indicated: 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.

More studies in Chronic Low-back Pain

Psilocybin Therapy for Chronic Low Back Pain — San Francisco, California
Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain — San Francisco, California
Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain — Kansas City, Kansas
Evaluation of Multi-Tined Expandable Electrode (MEE) Efficacy and Safety in Treatment of Lumbar Facet Arthropathy by Radiofrequency Neurotomies Compared to Conservative Medical Management. — Kansas City, Kansas
Psilocybin in Chronic Low Back Pain and Depression — Baltimore, Maryland

Explore by condition: All Chronic Low-back Pain clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗