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

NCT04042844 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2025-08-26

No results posted yet for this 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.

Conditions

  • Lumbar Disc Disease

Interventions

BIOLOGICAL

BRTX-100

Hypoxic cultured mesenchymal stem cells (MSCs) from autologous bone marrow with autologous platelet lysate.

DRUG

Saline

Sodium Chloride (0.9%) intravenous infusion preparation is a sterile and non-pyrogenic solution

Sponsors & Collaborators

  • BioRestorative Therapies

    lead INDUSTRY

Principal Investigators

  • Jason Lipitz, MD · BioRestorative Therapies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04042844 on ClinicalTrials.gov