A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease (NCT07254806)
A Prospective, Randomized, Double-Blinded, Sham-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of IDCT in Subjects With Single-Level, Symptomatic Mild to Moderate Lumbar Intervertebral Disc Degeneration
🩺 Plain-English Summary (8th-Grade Level)
This is a Phase III, randomized, double-blinded, Sham-controlled, multi-center study in subjects with single-level, symptomatic lumbar (L3- S1) intervertebral disc degeneration. The study will have a 52-week primary period followed by 52 week Follow-up Period (total of 104 weeks). The study protocol will be approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), and the study will be conducted in accordance with Good Clinical Practice (GCP). All subjects will provide written informed consent prior to Screening. Approximately 162 subjects will be enrolled in the study. Up to 45 days prior to treatment, subjects will be screened for study inclusion, which includes obtaining baseline MRI and X-ray imaging. Imaging results for subjects initially eligible for study participation will be sent to a central imaging vendor for review and confirmation of eligibility, including the number of levels with degeneration. Subjects meeting all inclusion/exclusion criteria will be assigned to the corresponding treatment arm group and subsequently randomized to IDCT or Sham. Randomization will occur approximately 7 to 14 days prior to the scheduled treatment administration date. Overall, 162 subjects will be enrolled and randomized to IDCT or Sham in a 2:1 ratio. * IDCT (n=108) * Sham (n=54)
Who can join: Review the eligibility criteria below.
Location: Alabama Clinical Therapeutics — Birmingham, Alabama
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (24 Sites)
- Alabama Clinical Therapeutics — Birmingham, Alabama
- Mayo Clinic (AZ) — Phoenix, Arizona
- Solaris Research Institute — San Diego, California
- Source Healthcare — Santa Monica, California
- Pain Management and Injury Relief — Thousand Oaks, California
- International Spine, Pain and Performance Center — Washington D.C., District of Columbia
- Mayo Clinic (FL) — Jacksonville, Florida
- Conquest Research — Orlando, Florida
- Vantage Clinical Trials — St. Petersburg, Florida
- Vantage Clinical Trials — Tampa, Florida
- Injury Care Family Care Research — Boise, Idaho
- Axis Spine Center — Post Falls, Idaho
- Indiana Spine Group — Carmel, Indiana
- Mayo Clinic (MN) — Rochester, Minnesota
- The Orthopedic Center of St. Louis — St Louis, Missouri
- Weill Cornell Medicine for Comprehensive Spine Care — New York, New York
- Wake Research — Wilmington, North Carolina
- Carolinas Pain Institute/ Center For Clinical Research — Winston-Salem, North Carolina
- Cleveland Clinic — Cleveland, Ohio
- Pacific Sports and Spine — Eugene, Oregon
- Semmes Murphey Neurological Clinic — Memphis, Tennessee
- Pain Specialists of America — Austin, Texas
- University of Utah — Salt Lake City, Utah
- Virginia iSpine Physicians — Richmond, Virginia
📞 Contact the Study Coordinator
Phone: (205) 833-2228
Email: bailey.murphy@actstudy.net
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.