Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatm… (NCT06053242) | Clinical Trial Compass
RecruitingPhase 1/2
Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain
United States45 participantsStarted 2024-05-21
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* History of cancer in the last five years.
* Spinal infections and spinal tumors.
* Renal insufficiency requiring…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.