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

NCT06053242 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CELZ-201-ADAPT
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Low-back Pain; Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• Evaluate safety of CELZ-201-DDT administered as intramuscular injections in subjects experiencing chronic lower back pain at a low, medium, or high dose.

  The primary outcome will be evaluated by the incidence of grade 3 or 4 or serious adverse events in all dosing cohorts at 6 months.

  6 months

Secondary Outcomes (3)

• Evaluate the potential efficacy of CELZ-201-DDT therapy in terms of pain alleviation and improved mobility in subjects experiencing chronic low back pain.

  12 months

• Evaluate the potential efficacy of CELZ-201-DDT therapy in terms of pain alleviation and improved mobility in subjects experiencing chronic low back pain.

  12 months

• Evaluate the potential efficacy of CELZ-201-DDT therapy in terms of pain alleviation and improved mobility in subjects experiencing chronic low back pain.

  12 months

Study Arms (4)

Low Dose

EXPERIMENTAL

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.

Drug: CELZ-201-DDT; Other: Placebo

Medium Dose

EXPERIMENTAL

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.

Drug: CELZ-201-DDT; Other: Placebo

High Dose

EXPERIMENTAL

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.

Drug: CELZ-201-DDT; Other: Placebo

Expanded High Dose

EXPERIMENTAL

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.

Drug: CELZ-201-DDT; Other: Placebo

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.

Expanded High Dose; High Dose; Low Dose; Medium Dose

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.

Expanded High Dose; High Dose; Low Dose; Medium Dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Recent smoking history or substance abuse (within six weeks).
• Heavy alcohol use (greater than 14 drinks per week for men or 7 drinks per week for women per NIAAA)
• Use of an investigational drug, device or product, or participation in a drug research study within a period of 30 days prior to receiving study treatment.
• Any patient who has received gene therapy in the past.

Sponsors & Collaborators

• Creative Medical Technology Holdings Inc: lead

Study Sites (1)

Spine and Wellness Centers of America

Aventura, Florida, 33180, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Creative Medical Technology

CONTACT

(702) 588-1890; clinicaltrials@creativemedicaltechnology.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: September 25, 2023
• Study Start: May 21, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)