NCT04042844Phase 2Recruiting

A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2026-12Estimated

Enrollment · participants99Estimated

Source updated2025-08-26Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Lumbar Disc Disease

Treatments or interventions studied

BRTX-100Biological
SalineDrug

Primary outcomes · main study measures

Read the study measures

measure: Primary Safety Measures; description: 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); timeFrame: Baseline through Week 104 / Early Termination; measure: Primary Efficacy Measures; description: * 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.; timeFrame: Baseline through Week 52

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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