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Tests treatment safety and results for Chronic Low-back Pain
Official title Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain
ClinicalTrials.gov ID: NCT06053242
What this study is testing
What is CELZ-201-DDT?
CELZ-201-DDT is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic low-back pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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.
- people must have failed at least two standard of care (SOC) therapies before being enrolled in the study: 1) exercise/physical therapy; 2) oral...
- 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...
You likely can't join 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.
See the full eligibility 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.
- people 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...
- 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...
- Female people 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.
- people may be on stable opioids, narcotics, or muscle relaxants for ≥30 days before screening.
- 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 people have their hypertension appropriately treated, then they would be...
- 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.
- people 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.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aventura, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aventura, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.