Drugs / BRTX-100
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT04042844 | Jun 2022 → Dec 2026 expected | lumbar disk disease | BioRestorative Therapies | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2026-05-07 | BioRestorative Therapies | Results BioRestorative Therapies Reports Expanded Phase 2 Blinded Dataset for BRTX-100 Showing Sustained Pain and Functional Improvements in Chronic Lumbar Disc Disease biorestorative.com ↗
At 52 weeks, 52% of evaluable patients achieved at least 50% improvement in both the Visual Analog Scale (“VAS”) for pain and the Oswestry Disability Index (“ODI”) for function. |
| 2026-03-30 | BioRestorative Therapies | Results BioRestorative Therapies Reports Positive Phase 2 Blinded Data for BRTX-100 Demonstrating Meaningful Improvements in Pain and Function in Chronic Lumbar Disc Disease biorestorative.com ↗ |
| 2025-11-17 | BioRestorative Therapies | Regulatory BioRestorative Granted Type B Meeting with FDA to Discuss Accelerated BLA Approval Pathway for BRTX-100 in Chronic Lumbar Disc Disease biorestorative.com ↗
BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a regenerative medicine innovator focused on stem cell-based therapies and products, today announced that it has been granted a Type B meeting with the U.S. Food and Drug Administration (“FDA”) to discuss a potential accelerated Biologics License Application (“BLA”) approval pathway for the Fast-Track-Designated BRTX-100 program for the treatment of chronic lumbar disc disease (“cLDD”). |
| 2025-06-13 | BioRestorative Therapies | Results BioRestorative Reports Compelling Preliminary Data for FDA-Fast-Tracked BRTX-100 – an Autologous Stem Cell Therapy to Treat Chronic Lumbar Disc Disease biorestorative.com ↗
BioRestorative Therapies, Inc. (“BioRestorative,” “BRTX” or the “Company”) (NASDAQ: BRTX), a clinical-stage regenerative medicine company developing stem cell-based therapies for serious musculoskeletal conditions, today announced the presentation of promising preliminary blinded data from the first 36 subjects in its ongoing Phase 2 clinical trial of BRTX-100, an autologous stem cell therapy for chronic lumbar disc disease (cLDD). |
| 2025-05-13 | BioRestorative Therapies | Results Phase 2 Trial of BRTX-100 in cLDD Continues to Generate Positive Preliminary Blinded Data biorestorative.com ↗
No serious adverse events (SAEs) were reported, and there was no dose (40X106 cells) limiting toxicity at 26-104 weeks. |
| 2025-02-27 | BioRestorative Therapies | Regulatory BioRestorative Announces FDA Clearance of IND for Phase 2 Trial of BRTX-100 in Chronic Cervical Discogenic Pain biorestorative.com ↗
IND clearance expands Company’s advanced clinical pipeline for BRTX-100 treatment of both chronic lower back and neck pain |
| 2025-02-20 | BioRestorative Therapies | Regulatory BioRestorative Receives FDA Fast Track Designation for BRTX-100 Chronic Lumbar Disc Disease Program biorestorative.com ↗
the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to the BRTX-100 program for the treatment chronic lumbar disc disease (“cLDD”). |
| 2025-02-10 | BioRestorative Therapies | Results BRTX-100 Front and Center at ORS 2025 biorestorative.com ↗
Among other positive preliminary data analyses, comparison of MRI images to baseline potentially demonstrate disc microenvironment remodeling |
| 2024-11-13 | BioRestorative Therapies | Results BioRestorative Therapies Reports Positive Preliminary Phase 2 BRTX-100 Clinical Data biorestorative.com ↗
today announced new preliminary 26–52 week blinded data from the first 10 patients with chronic lumbar disc disease (“cLDD”) enrolled in the ongoing Phase 2 clinical trial of BRTX-100. |
| 2024-04-16 | BioRestorative Therapies | Regulatory BioRestorative Therapies Announces FDA Clearance of Phase 2 BRTX-100 Clinical Study Protocol Amendment biorestorative.com ↗ |
| 2024-02-05 | BioRestorative Therapies | Results BioRestorative Therapies Presents Preliminary Clinical Data from Phase 2 Study of BRTX-100 in Chronic Lumbar Disc Disease biorestorative.com ↗
Although this is blinded and early clinical data, it is important to note that the Visual Analog Scale, Oswestry Disability Index, Roland Morris Disability Questionnaire, and Functional Rating Index collected at weeks 26 and 52 post-injection demonstrated a positive trend compared to baseline. |
| 2023-06-27 | BioRestorative Therapies | Results BioRestorative Therapies Receives Unanimous Recommendation from Data Safety Monitoring Board (DSMB) to Continue its Phase 2 Clinical Trial without any Changes biorestorative.com ↗
There were no DLTs observed in the patients within the safety run segment of the study. |
| 2022-09-01 | BioRestorative Therapies | Regulatory Obesity And Back Pain: BioRestorative Therapies Inc. Is Working To Address 2 Common Ailments That Plague Americans with a Major Near Term Data Catalyst biorestorative.com ↗
The Food and Drug Administration (FDA) has authorized BioRestorative to begin a Phase 2 clinical trial using BRTX-100 to treat persistent lower back pain resulting from pain-causing degenerative discs. |
| 2022-02-16 | BioRestorative Therapies | Regulatory BioRestorative Therapies Announces Notice of Allowance on Key Patent for its BRTX-100® Disc Program biorestorative.com ↗
BioRestorative Therapies, Inc. (the “Company” or “BioRestorative”) (NASDAQ: BRTX), a clinical stage company focused on stem cell-based therapies, today announced that the United States Patent and Trademark Office has issued a notice of allowance for a patent application related to the Company’s BRTX-100® core clinical program. |
| 2018-08-15 | BioRestorative Therapies | Results BioRestorative Therapies Announces Publication of Study Results Validating the Benefits of Using Hypoxic Cultured Cells to Treat Patients with Degenerative Disc Disease biorestorative.com ↗
Based on the study results, expanding cells in hypoxic culture conditions impacts cell fitness and gene expression that may contribute to cell potency and therapeutic benefits. |
| 2018-06-11 | BioRestorative Therapies | Results BioRestorative Therapies Reports Positive Findings from Independent Review of its BRTX-100 Program biorestorative.com ↗
As noted in the report, the KOLs reacted positively to the value proposition of BRTX-100 and were optimistic that the clinical data presented to date is likely to be mirrored in future clinical investigations. |
| 2017-10-05 | BioRestorative Therapies | Results BioRestorative Therapies Announces Published Study of Licensed Technology to Treat Lumbar Degenerative Disc Disease biorestorative.com ↗
The study, by a physician group based in Colorado, entitled “Treatment of lumbar degenerative disc disease-associated radicular pain with culture-expanded autologous mesenchymal stem cells: a pilot study on safety and efficacy,” reported significant improvements in pain and function as well as overall subjective improvement. |
| 2017-02-08 | BioRestorative Therapies | Regulatory BioRestorative Therapies Receives FDA Clearance to Initiate Phase 2 Clinical Trial for the Treatment of Patients with Degenerative Disc Disease biorestorative.com ↗ |
| 2017-01-09 | BioRestorative Therapies | Regulatory BioRestorative Therapies Submits IND Application to FDA to Treat Patients with Degenerative Disc Disease biorestorative.com ↗
We are pleased to have this IND under review by the FDA, |
| 2016-09-12 | BioRestorative Therapies | Results BioRestorative Therapies Announces Publication in Medical Journal of Positive Results of Long-Term Safety and Feasibility Study Using Cell Therapy to Treat Patients with Degenerative Disc Disease biorestorative.com ↗
According to the publication, early human clinical data suggests safety and feasibility for the clinical use of hypoxic cultured bone marrow-derived mesenchymal stem cells for the treatment of lower back pain due to degenerative disc disorder. |
| 2016-06-28 | BioRestorative Therapies | Results BioRestorative Therapies Announces Completion of Human Safety and Feasibility Study on the Use of Hypoxic Cultured Stem Cells to Treat Chronic Lower Back Pain biorestorative.com ↗
The study showed that no adverse events related to the intra-discal injection of autologous, hypoxic cultured, bone marrow-derived mesenchymal stem cells (MSCs) occurred at the time of injection or up to 6 years post-injection, demonstrating initial long-term safety. |
All press releases naming this drug 37 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BRTX-100 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04042844 ↗ |
| Modality | Cell therapy | “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...” NCT04042844 ↗ |