BRTX-100 for Chronic Lumbar Disc Disease
This study is testing a single dose of BRTX-100, which is made from your own bone marrow stem cells, for people with chronic lumbar disc disease (cLDD). This condition causes ongoing back pain due to changes in the discs of your spine. Researchers want to see if BRTX-100 is safe and effective compared to a saline (saltwater) injection. You might be able to join if you are an adult with chronic lower back pain for at least 6 months and have signs of disc problems. The study will look at your safety for up to 104 weeks and how well the treatment works for up to 52 weeks.
- Study design
- This is a double-blind, controlled, and randomized study, meaning neither you nor your doctors will know if you receive BRTX-100 or saline. It plans to enroll 99 participants.
- What's involved
- If you receive BRTX-100, you will have a bone marrow harvest and an injection into your disc. You will have follow-up visits at Week 2, Week 12, Week 26, Week 52, and Week 104/Early Termination.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety for up to 104 weeks and for treatment effectiveness for up to 52 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)
At a glance
Conditions
NCT04042844
Where you'd take part
This study runs at 19 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Boomerang Healthcare
Walnut Creek, Californiastudy coordinator listed
Recruiting
Cleveland Clinic
Cleveland, Ohiostudy coordinator listed
Recruiting
Coastal Health
Jacksonville, Floridastudy coordinator listed
Recruiting
Conquest Research
Winter Park, Floridastudy coordinator listed
Recruiting
Denver Back Pain Specialists, LLC
Greenwood Village, Coloradostudy coordinator listed
Recruiting
Florida Pain Relief Center
Tampa, Floridastudy coordinator listed
Recruiting
NCP Center for Clinical Research and Innovation
Houston, Texasstudy coordinator listed
Recruiting
Northwell Health
New York, New Yorkstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Jason Lipitz, MD · STUDY_CHAIR · BioRestorative Therapies
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Primary Safety MeasuresBaseline through Week 104 / Early Termination
Report of adverse events (AEs), clinical review and questionnaires for pain, disability and quality of life at Baseline through Week 104/ Early Termination * Vital Signs * Physical Examination * Laboratory Evaluation (hematology and chemistry) * Clinical review of MRI changes from Baseline to Week 104 (MRI density measurements in T2 weighted images performed at Baseline, Week 52 and Week 104 with predetermined MRI rating scores)
- Primary Efficacy MeasuresBaseline through Week 52
* VAS for Pain Assessment * ODI for Functional Assessment Primary Efficacy Endpoint: Clinical response, defined as at least a 30% decrease in pain as measured on the VAS scale and at least a 30% increase in function based on the ODI at Week 52 as compared to baseline.