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

NCT04042844 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CLDD-001
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 19

Brief 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

Outcome Measures

Primary Outcomes (2)

• Primary Safety Measures

  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)

  Baseline through Week 104 / Early Termination

• Primary Efficacy Measures

  * 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.

  Baseline through Week 52

Study Arms (2)

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.

Biological: BRTX-100

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.

Drug: Saline

Interventions

BRTX-100 BIOLOGICAL

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

Active Treatment- BRTX-100

Saline DRUG

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

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Chronic Lower Back Pain for at least 6 months
• Pain commonly provoked by prolonged sitting, forward bending, lifting, twisting, coughing, sneezing, or Valsalva maneuvers
• Failure of at least 6 months of conservative back pain care (can include any or all of the following: rest, anti-inflammatory medication, analgesics, narcotics, epidural injections or selective nerve root injections at the target level, facet joint injections, muscle relaxers, massage, acupuncture, chiropractic care)
• Failure of supervised therapy (such as physical therapy)
• Screening of ≥ 40 mm and ≤ 80 mm on low back pain visual analog scales (VAS) (average pain in the last week)
• Screening Oswestry Disability Index (ODI) score ≥ 30 and \< 90 on a 100-point scale
• No localized and significant pain below beltline (i.e., potential sacroiliac joint pain) without lumbar pain component
• Thigh or Leg pain, if present, is non prevailing and of nonradicular origin, i.e., not due to stimulation of nerve roots or dorsal root ganglion of a spinal nerve by compressive forces
• Diagnostic medial branch block or facet joint injection (bilateral unless the symptoms are purely unilateral in nature) in the last 12 months prior to the informed consent date indicates no prevailing facet joint involvement
• Has degenerative disc disease (DDD) as defined by the following:
• Changes from normal disc morphology of the affected disc as defined by radiographic evaluation
• Modified Pfirrmann score of 2 to 7 on MRI, may contain a contained protrusion and/or annular tear on MRI
• Modified Pfirrmann score of 1 must contain a contained protrusion and/or annular tear on MRI
• Modic Grade I or II changes or no change on MRI

You may not qualify if:

• A subject is not eligible to participate if any of the following criteria are met:
• Spinal Deformity (Scoliosis greater than or equal to 20 degrees, spondylolysis, clinically or radiographically significant retrolisthesis or spondylolisthesis) detected on MRI or plain film radiographic assessment
• Disc extrusions, sequestered fragments, facet cysts, or greater than moderate spinal stenosis on MRI.
• Presence of a Grade V annular fissure observed within the index disc level during discography in a subject for whom provocation discography has been performed
• Intervertebral disc with radiographic evidence of Modified Pfirrmann Grade 8 or greater
• Any bleeding disorder, intrinsic or extrinsic
• Required anticoagulation (with either antiplatelet agents or antithrombotics) that cannot be interrupted for harvest and injection procedures
• Platelet count less than or equal to 100,000
• International Normalized Ratio (INR) greater than or equal to 1.5
• Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI greater than or equal to 40)
• Clinically relevant instability on flexion-extension as determined by the investigator by overlaying films (flexion \& extension films)
• Has undergone any previous lumbosacral spine surgery (e.g. discectomy, laminectomy, foraminotomy, fusion, intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation.), ablation of lumbar basiverterbral nerve or therapeutic percutaneous disc intervention
• Have any acute or chronic lumbosacral spine fracture
• Have a history of lumbosacral epidural steroid injections within 1 month prior to informed consent date.
• Planned/expected use of systemic nonsteroidal anti-inflammatory drugs (NSAIDs) within 72 hours prior to study treatment.

Sponsors & Collaborators

• BioRestorative Therapies: lead

Study Sites (19)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

WITHDRAWN

Source Healthcare

Santa Monica, California, 90403, United States

RECRUITING

Boomerang Healthcare

Walnut Creek, California, 94598, United States

RECRUITING

Denver Back Pain Specialists, LLC

Greenwood Village, Colorado, 80111, United States

RECRUITING

Cantor Spine Institute

Fort Lauderdale, Florida, 33306, United States

WITHDRAWN

Coastal Health

Jacksonville, Florida, 32257, United States

RECRUITING

Pain Relief Centers

St. Petersburg, Florida, 33709, United States

RECRUITING

Tampa Pain Relief Center

Tampa, Florida, 33603, United States

RECRUITING

Florida Pain Relief Center

Tampa, Florida, 33614, United States

RECRUITING

Conquest Research

Winter Park, Florida, 32789, United States

RECRUITING

Northwell Health

New York, New York, 10022, United States

RECRUITING

The Center of Clinical Research, LLC

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Clinical Investigations LLC

Edmond, Oklahoma, 73013, United States

WITHDRAWN

Coastal Carolina Research Center

North Charleston, South Carolina, 29406,, United States

WITHDRAWN

Science Connections

Austin, Texas, 78758, United States

RECRUITING

NCP Center for Clinical Research and Innovation

Houston, Texas, 77008, United States

RECRUITING

Precision Spine Care

Tyler, Texas, 75701, United States

WITHDRAWN

Virginia iSpine Physicians

Richmond, Virginia, 23235, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral disc disease

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jason Lipitz, MD

  BioRestorative Therapies

  STUDY CHAIR

Central Study Contacts

Francisco Silva

CONTACT

1(949)394-0132; FSilva@biorestorative.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects will be randomized (2:1) to receive either intradiscal BRTX-100 or control.

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 2, 2019
• Study Start: June 30, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)