deltatrials
Active Not Recruiting PHASE1/PHASE2 INTERVENTIONAL 2-arm NCT03042143

Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration (REALIST) (REALIST)

Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration (REALIST): An Open Label Dose Escalation Phase 1 Trial Followed by a Randomised, Double-blind, Allocation Concealed, Placebo-controlled Trial.

Sponsor: Belfast Health and Social Care Trust

Conditions Acute Respiratory Distress Syndrome
Interventions Human umbilical cord derived CD362 enriched MSCs Placebo (Plasma-Lyte 148)
Updated 13 times since 2017 Last updated: Sep 1, 2025 Started: Jan 7, 2019 Primary completion: Apr 30, 2026 Completion: Oct 31, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03042143, this PHASE1/PHASE2 trial focuses on Acute Respiratory Distress Syndrome and remains ongoing. Sponsored by Belfast Health and Social Care Trust, it has been updated 13 times since 2019, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Dec 2018 · 4 months · monthly snapshot~Dec 2018 – ~Feb 2019 · 2 months · monthly snapshot~Feb 2019 – ~May 2020 · 15 months · monthly snapshot~May 2020 – ~Jan 2021 · 8 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Jun 2022 · 9 months · monthly snapshot~Jun 2022 – ~Jun 2023 · 12 months · monthly snapshot~Jun 2023 – ~Jul 2024 · 13 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2025 · 13 months · monthly snapshot~Oct 2025 – present · 9 months · monthly snapshot

Change History

13 versions recorded

  1. Oct 2025 — Present [monthly]

    Active Not Recruiting PHASE1/PHASE2

  2. Sep 2024 — Oct 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

    Status: Recruiting → Active Not Recruiting

  3. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  4. Jun 2023 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

  5. Jun 2022 — Jun 2023 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Active Not Recruiting → Recruiting

▶ Show 8 earlier versions

  1. Sep 2021 — Jun 2022 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

  2. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE1_PHASE2

  3. May 2020 — Jan 2021 [monthly]

    Recruiting PHASE1_PHASE2

  4. Feb 2019 — May 2020 [monthly]

    Recruiting PHASE1_PHASE2

  5. Dec 2018 — Feb 2019 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet Recruiting → Recruiting

  6. Aug 2018 — Dec 2018 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

  7. Jun 2018 — Aug 2018 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

  8. Feb 2017 — Jun 2018 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Belfast Health and Social Care Trust
  • NHS Blood and Transplant
  • Northern Ireland Clinical Trials Unit
  • Queen's University, Belfast
Data source: Belfast Health and Social Care Trust

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

Study Locations