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

Launched by CREATIVE MEDICAL TECHNOLOGY HOLDINGS INC · Sep 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CELZ-201-DDT, which is given as an injection in the muscle near the spine, for people suffering from chronic lower back pain. The main goal is to find out if this treatment is safe, how well it is tolerated, and whether it effectively helps relieve pain. Researchers are looking for participants who are between 18 and 80 years old and have already tried at least two standard treatments for their back pain, such as physical therapy and pain-relieving medications, without success.

To participate, individuals must have certain types of back pain, proven by tests like MRI scans. Women need to ensure they are not pregnant or breastfeeding, and men must agree to use contraceptives during the study. Participants can expect to undergo health screenings and receive the injection as part of the trial. This is an exciting opportunity for those who have not found relief from their back pain through other means, but it's important to know that there are specific health criteria that must be met to join the study. If you think you might be eligible, you can discuss this with your healthcare provider.

Gender

ALL

Eligibility criteria

• 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.
• 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 who are currently on opioid medication(s).
• • Body Mass Index (BMI) \> 40 kg/m2.