A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)
ConditionLumbar Disc Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioRestorative Therapies
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
BRTX-100
Biological/VaccineHypoxic cultured mesenchymal stem cells (MSCs) from autologous bone marrow with autologous platelet lysate.
Saline
DrugSodium Chloride (0.9%) intravenous infusion preparation is a sterile and non-pyrogenic solution
Treatment groups
99 Participants
are divided into 2 treatment groupsGroup A: Active Treatment- BRTX-100Experimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
Baseline through Week 104 / Early Termination2
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.
Time frame
Baseline through Week 52Sponsors and contacts
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Source ClinicalTrials.gov