Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04042844 · ClinicalTrials.gov registry record · Phase 2
A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)
A Phase 2 study of Lumbar Disc Disease, sponsored by BioRestorative Therapies.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 99
- Enrollment target
- 19
- Study locations
NCT04042844: Recruiting Phase 2 study of Lumbar Disc Disease, sponsored by BioRestorative Therapies.
NCT04042844 is a Phase 2 study of Lumbar Disc Disease that is actively recruiting participants, run by BioRestorative Therapies. The registered enrollment target is 99 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). The trial reports 19 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04042844, a Phase 2 study of Lumbar Disc Disease, is actively recruiting participants, sponsored by BioRestorative Therapies.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 99 participants
- Enrollment target
- 19
- Study locations
Study Summary
This is a double-blind, controlled, randomized study with blinded assessments using a single dose. Subjects that have a current diagnosis of chronic lumbar disc disease and meet eligibility criteria will be enrolled. Chronic lumbar disc disease is defined as back and/or radicular pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic measures such as computed tomography (CT), magnetic resonance imaging (MRI), plain film, myelography, discography, or other acceptable means.
Primary Outcome
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)
Conditions Studied
Interventions
- DRUG Saline
- BIOLOGICAL BRTX-100
Study Locations (19)
Florida
- Cantor Spine Institute - Fort Lauderdale
- Coastal Health - Jacksonville
- Pain Relief Centers - St. Petersburg
- Tampa Pain Relief Center - Tampa
- Florida Pain Relief Center - Tampa
- Conquest Research - Winter Park
Texas
- Science Connections - Austin
- NCP Center for Clinical Research and Innovation - Houston
- Precision Spine Care - Tyler
California
- Source Healthcare - Santa Monica
- Boomerang Healthcare - Walnut Creek
Alabama
- Alabama Clinical Therapeutics, LLC - Birmingham
Colorado
- Denver Back Pain Specialists, LLC - Greenwood Village
New York
- Northwell Health - New York
North Carolina
- The Center of Clinical Research, LLC - Winston-Salem
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2022-06-30 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What NCT04042844 shows while recruiting
NCT04042844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 1 condition, with Lumbar Disc Disease appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.
NCT04042844 lists 19 locations in 11 states (Florida, Texas, California).
Frequently Asked Questions
What is clinical trial NCT04042844 about?
NCT04042844 is a clinical study titled "A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)". This is a double-blind, controlled, randomized study with blinded assessments using a single dose. Subjects that have a current diagnosis of chronic lumbar disc disease and meet eligibility criteria will be enrolled. Chronic lumbar disc disease is defined as back and/or radicular pain with degenerat...
What is the current status of trial NCT04042844?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2022-06-30. Estimated completion is 2027-12.
What conditions does trial NCT04042844 study?
This clinical trial studies the following conditions: Lumbar Disc Disease.
What interventions are being tested in trial NCT04042844?
The interventions under investigation include: Saline (DRUG), BRTX-100 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04042844?
This trial is sponsored by BioRestorative Therapies, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04042844 being conducted?
This trial has 19 study locations across Alabama, California, Colorado, Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lumbar Disc Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04042844's enrollment target sits among peer trials
99 738th of 2000 higher than 1,258 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03965234 · 99 participants · Phase 1
Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorectal Metastases
- NCT04022616 · 99 participants
Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients
- NCT04143724 · 99 participants · Phase 2
Study of Safety & PK of Luspatercept (ACE-536) in Pediatric Participants With Beta (β)-Thalassemia
- NCT04302025 · 99 participants · Phase 2
A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI