deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 2-arm NCT04537026

Sterile Amniotic Fluid Filtrate Epidural Injection.

A Phase I/II Double-Blinded Randomized Prospective Study of Sterile Amniotic Fluid Filtrate Epidural Injection for the Treatment of Lumbosacral Radicular Pain Due to Spinal Stenosis: Improving Safety and Outcomes in the Treatment of Pain and Disability Related to Spinal Stenosis.

Sponsor: Cell Therapy & Regenerative Medicine

Conditions Lumbar Spinal Stenosis
Interventions Amniotic Fluid Allograft Dexamethasone sodium phosphate
Updated 17 times since 2020 Last updated: Sep 22, 2025 Started: Jun 16, 2021 Primary completion: Jul 1, 2025 Completion: Jul 1, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Lumbar Spinal Stenosis and is currently completed. Cell Therapy & Regenerative Medicine leads this study, which shows 17 recorded versions since 2021 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Oct 2020 – ~Dec 2020 · 2 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~Jun 2021 · 2 months · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Nov 2021 · 2 months · monthly snapshot~Nov 2021 – ~Jan 2022 · 2 months · monthly snapshot~Jan 2022 – ~Dec 2022 · 11 months · monthly snapshot~Dec 2022 – ~Jan 2024 · 13 months · monthly snapshot~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshot~Jan 2025 – ~Apr 2025 · 3 months · monthly snapshot~Apr 2025 – ~Jun 2025 · 2 months · monthly snapshot~Jun 2025 – ~Oct 2025 · 4 months · monthly snapshot~Oct 2025 – present · 9 months · monthly snapshot

Change History

17 versions recorded

  1. Oct 2025 — Present [monthly]

    Completed PHASE1/PHASE2

    Status: Active Not Recruiting → Completed

  2. Jun 2025 — Oct 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

    Status: Recruiting → Active Not Recruiting

  3. Apr 2025 — Jun 2025 [monthly]

    Recruiting PHASE1/PHASE2

  4. Jan 2025 — Apr 2025 [monthly]

    Recruiting PHASE1/PHASE2

  5. Sep 2024 — Jan 2025 [monthly]

    Recruiting PHASE1/PHASE2

▶ Show 12 earlier versions

  1. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  2. Jan 2024 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

  3. Dec 2022 — Jan 2024 [monthly]

    Recruiting PHASE1_PHASE2

  4. Jan 2022 — Dec 2022 [monthly]

    Recruiting PHASE1_PHASE2

  5. Nov 2021 — Jan 2022 [monthly]

    Recruiting PHASE1_PHASE2

  6. Sep 2021 — Nov 2021 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet Recruiting → Recruiting

  7. Jun 2021 — Sep 2021 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

  8. Apr 2021 — Jun 2021 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

  9. Mar 2021 — Apr 2021 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

  10. Jan 2021 — Mar 2021 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

  11. Dec 2020 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

  12. Oct 2020 — Dec 2020 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Cell Therapy & Regenerative Medicine
  • University of Utah
Data source: University of Utah

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

Study Locations