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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Aug 31, 2024 to Dec 2026v10 Show 4 more changesShow less
    • Study sites: 14 to 19
    • Study completion date: Aug 31, 2025 to Dec 2027
    • Eligibility criteria expanded, about 249 words
    • Study description shortened, about 1 word
  2. Study sites: 16 to 14v9
  3. Primary endpoints: 1 to 2
    • Study sites: 15 to 16
    • Secondary endpoints shortened, about 43 words
    v8
  4. Study sites: 14 to 15
    • Eligibility criteria expanded, about 27 words
    v7
  5. Site details revised at 12 of 14 sitesv6
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  1. Trial status: Not Yet Recruiting to Recruitingv5 Show 6 more changesShow less
    • Primary completion date: Jun 2, 2023 to Aug 31, 2024
    • Start date changed from estimate of Mar 2, 2021 to Jun 30, 2022
    • Study sites: 0 to 14
    • Study completion date: Aug 31, 2023 to Aug 31, 2025
    • Study description expanded, about 192 words
    • Eligibility criteria expanded, about 2 words
  2. Start date: Jun 2, 2020 to Mar 2, 2021v4
  3. Start date: Feb 2, 2020 to Jun 2, 2020
    • Primary completion date: Feb 2, 2023 to Jun 2, 2023
    • Study completion date: Mar 31, 2023 to Aug 31, 2023
    v3
  4. Interventions: BRTX-100 (Biological) to BRTX-100 (Biological), Saline (Drug)
    • Secondary endpoints revised (2)
    • Study title shortened, about 7 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04042844
Lead Sponsor BioRestorative Therapies
Conditions
(from sponsor)		 Lumbar Disc Disease
Related terms Intervertebral disc disease
Enrollment 99 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov