New injection could ease chronic back pain without surgery
NCT ID NCT06053242
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This study is testing an experimental injection called CELZ-201-DDT for people with long-term lower back pain caused by degenerative disc disease. The goal is to see if it is safe and can reduce pain and improve movement. About 45 adults aged 18 to 80 who have not gotten relief from standard treatments like physical therapy or pain pills will receive either the study drug or a placebo.
Why investors are watching
Creative Medical Technology Holdings is running an early-stage trial of CELZ-201-DDT, an injected treatment for chronic lower back pain from degenerative disc disease. The trial enrolls 45 participants and compares the drug against a placebo in a blinded, dose-escalation design. For a micro-cap company with few products, this readout could define whether its pipeline has a viable lead asset.
If it works: A positive safety and pain-relief signal could support further development and raise the drug's profile with partners or investors. Success in a common condition like lower back pain might open a large patient market if later trials confirm the effect.
If it fails: Early-stage trials often fail to show benefit, and this one is small, so results may be inconclusive or negative. A failure or delay could leave the company without a clear pipeline advance and put pressure on its limited resources.
AI-written from the trial record. Speculative, and not investment advice.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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. * Subjects with an average baseline MED \>90 mg/day during the screening period are excluded. The average will be calculated over a 7-day time period. * Body Mass Index (BMI) \> 40 kg/m2.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Spine and Wellness Centers of America
Aventura, Florida, 33180, United States
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Other studies related to the condition(s) this trial covers.
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