Who is eligible for clinical trial NCT06053242?

Participants must meet protocol criteria for Chronic Low-back Pain. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06053242 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ 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)

🔵 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

📋 "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.

🏛️ View Official NIH Record ↗