Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BRTX-100 · 1 trial · 1 indication
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 ...
BRTX-100 is an investigational monoclonal antibody being developed for the treatment of Lumbar Disc Disease, a musculoskeletal condition. It is currently in Phase 2 clinical development and has been granted Fast Track designation by the FDA. The drug is administered as a single dose to patients with chronic lumbar disc disease.
BRTX-100 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being studied for its potential to treat Lumbar Disc Disease, a condition affecting the intervertebral discs of the lower spine. Its mechanism of action is not publicly detailed.
BRTX-100 is being developed by BioRestorative Therapies, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol BRTX. The company is conducting clinical trials to evaluate the safety and efficacy of BRTX-100 for the treatment of Lumbar Disc Disease.
BRTX-100 is currently in Phase 2 clinical development. It is an investigational drug and has not yet been approved by the FDA. The drug has received Fast Track designation, which is intended to facilitate its development and expedite its review process for the treatment of Lumbar Disc Disease.
BRTX-100 is being evaluated in a Phase 2 clinical trial identified as NCT04042844. This randomized, double-blind, sham-controlled study is recruiting 99 participants in the United States to assess the effects of a single dose of BRTX-100 in patients with chronic lumbar disc disease. The trial is currently recruiting participants aged 18 years and older.
Yes, BRTX-100 and BRTX 100 refer to the same investigational drug. The clinical trial NCT04042844 uses the title 'A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)', confirming that BRTX-100 and BRTX 100 are alternative names for the same drug being developed by BioRestorative Therapies.