deltatrials
Active Not Recruiting PHASE2/PHASE3 INTERVENTIONAL 2-arm NCT03737461

Efficacy of Intradiscal Injection of BM-MSC in Subjects With Chronic Low Back Pain (LBP) Due to Lumbar Degenerative Disc Disease (DDD) Unresponsive (RESPINE)

A Phase 2/3 Prospective, Multicentre Randomized, Double-blind Trial, Comparing Intra-discal Allogeneic Adult BM-MSC Therapy and Sham-treated Controls in Subjects With Chronic LBP Due to Lumbar DDD Unresponsive to Conventional Therapy

Sponsor: APHP

Updated 11 times since 2018 Last updated: Sep 24, 2025 Started: Feb 18, 2019 Primary completion: May 30, 2022 Completion: Mar 8, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2/PHASE3 clinical study on Degenerative Disc Disease (DDD) and Recurrent Low Back Pain, this trial is ongoing. The trial is conducted by APHP and has accumulated 11 data snapshots since 2019. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Dec 2018 – ~Jun 2019 · 6 months · monthly snapshotNot Yet Recruiting~Jun 2019 – ~May 2020 · 11 months · monthly snapshotRecruiting~May 2020 – ~Sep 2020 · 4 months · monthly snapshotRecruiting~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshotRecruiting~Jan 2021 – ~Jan 2022 · 12 months · monthly snapshotRecruiting~Jan 2022 – ~Sep 2022 · 8 months · monthly snapshotActive Not Recruiting~Sep 2022 – ~Sep 2023 · 12 months · monthly snapshotActive Not Recruiting~Sep 2023 – ~Jul 2024 · 10 months · monthly snapshotActive Not Recruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotActive Not Recruiting~Sep 2024 – ~Oct 2025 · 13 months · monthly snapshotActive Not Recruiting~Oct 2025 – present · 9 months · monthly snapshotActive Not Recruiting

Change History

11 versions recorded
  1. Oct 2025 — Present [monthly]

    Active Not Recruiting PHASE2/PHASE3

  2. Sep 2024 — Oct 2025 [monthly]

    Active Not Recruiting PHASE2/PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE2/PHASE3

    Phase: PHASE2_PHASE3PHASE2/PHASE3

  4. Sep 2023 — Jul 2024 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  5. Sep 2022 — Sep 2023 [monthly]

    Active Not Recruiting PHASE2_PHASE3

Show 6 earlier versions
  1. Jan 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE2_PHASE3

    Status: RecruitingActive Not Recruiting

  2. Jan 2021 — Jan 2022 [monthly]

    Recruiting PHASE2_PHASE3

  3. Sep 2020 — Jan 2021 [monthly]

    Recruiting PHASE2_PHASE3

  4. May 2020 — Sep 2020 [monthly]

    Recruiting PHASE2_PHASE3

  5. Jun 2019 — May 2020 [monthly]

    Recruiting PHASE2_PHASE3

    Status: Not Yet RecruitingRecruiting

  6. Dec 2018 — Jun 2019 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • APHP
  • BG Klinikum Bergmannstrost, Halle, Germany
  • Campus Bio-Medico University
  • Centre National de la Recherche Scientifique, France
  • Citospin
  • Département de l'information médicale, CHU de Montpellier
  • European Clinical Research Infrastructure Network
  • Institut de Terapia Regenerativa Tissular
  • Interdisziplinäres Zentrum Klinische Studien (IZKS)
  • Nantes University Hospital
  • National University of Ireland, Galway, Ireland
  • Rennes University Hospital
  • Univercell-Biosolutions S.A.S
  • University Hospital, Montpellier
  • University of Navarra
  • University of Valladolid
  • Université Montpellier
Data source: University Hospital, Montpellier

For direct contact, visit the study record on ClinicalTrials.gov .