Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04042844 | A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD) | PHASE2 | RECRUITING | 99 | — | — | Jun 30, 2022 | Dec 1, 2027 | Aug 26, 2025 | 19 | United States |
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)
* 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.
| Arm | Type | Description |
|---|---|---|
| Active Treatment- BRTX-100 | EXPERIMENTAL | BRTX-100 consists of a population of hypoxic-cultured bone marrow mononuclear cells highly enriched in mesenchymal stem cells from autologous bone marrow with autologous platelet lysate. |
| Sham | SHAM_COMPARATOR | Isotonic saline will be used as a control (sham) in this study. Drug: saline (0.9% sodium chloride). Please note this will be a sham procedure. This isotonic saline will not be injected intradiscally. |
| Name | Type | Description |
|---|---|---|
| BRTX-100 | BIOLOGICAL | Hypoxic cultured mesenchymal stem cells (MSCs) from autologous bone marrow with autologous platelet lysate. |
| Saline | DRUG | Sodium Chloride (0.9%) intravenous infusion preparation is a sterile and non-pyrogenic solution |
Subject Inclusion Criteria: A subject is eligible for inclusion if all the following criteria are met: 1. A high index of suspicion for discogenic pain, (i.e., painful degenerative disc(s) with or without protrusions less than or equal to 5 mm) 1. Chronic Lower Back Pain for at least 6 months ...