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

Conditions

• Lumbar Disc Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Jun 30, 2022

Status verified

Aug 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

99 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Active Treatment- BRTX-100
  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 Comparator: Sham
  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.

Primary Outcome Measure

Primary Safety Measures [ Time Frame: Baseline through Week 104 / Early Termination ]

Central Contacts

• Francisco Silva
  1(949)394-0132
  [email protected]

Locations (19)

Find similar trials in Birmingham, AL

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