deltatrials
Terminated PHASE1/PHASE2 INTERVENTIONAL 3-arm NCT00587990

Prospective Randomized Study of Mesenchymal Stem Cell Therapy in Patients Undergoing Cardiac Surgery (PROMETHEUS) (PROMETHEUS)

A Phase I/II, Randomized, Double-Blinded, Placebo-Controlled Study of the Safety and Efficacy of Intramyocardial Injection of Autologous Human Mesenchymal Stem Cells (MSCs) in Patients With Chronic Ischemic Left Ventricular Dysfunction Secondary to Myocardial Infarction (MI) Undergoing Cardiac Surgery for Coronary Artery Bypass Grafting (CABG)

Sponsor: Johns Hopkins University Specialized Center for Cell Based Therapy

Conditions Stem Cell Transplantation Ventricular Dysfunction, Left
Interventions Higher dose MSC injection Lower dose mesenchymal stem cell (MSC) injection Placebo
Updated 10 times since 2017 Last updated: Aug 19, 2019 Started: Nov 30, 2007 Primary completion: Jun 30, 2011 Completion: Jun 30, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Difficulty in recruitment.

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Listed as NCT00587990, this PHASE1/PHASE2 trial focuses on Stem Cell Transplantation and Ventricular Dysfunction, Left and remains terminated or withdrawn. Sponsored by Johns Hopkins University Specialized Center for Cell Based Therapy, it has been updated 10 times since 2007, reflecting substantial change activity. This study contributes longitudinal data to the cardiovascular research landscape.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Dec 2017 · 10 months · monthly snapshotCompleted~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshotCompleted~Jun 2018 – ~Jun 2019 · 12 months · monthly snapshotCompleted~Jun 2019 – ~Oct 2019 · 4 months · monthly snapshotCompleted~Oct 2019 – ~Jan 2021 · 15 months · monthly snapshotTerminated~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 22 months · monthly snapshotTerminated

Change History

10 versions recorded

  1. Sep 2024 — Present [monthly]

    Terminated PHASE1/PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  3. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE1_PHASE2

  4. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE1_PHASE2

  5. Oct 2019 — Jan 2021 [monthly]

    Terminated PHASE1_PHASE2

    Status: Completed → Terminated

▶ Show 5 earlier versions

  1. Jun 2019 — Oct 2019 [monthly]

    Completed PHASE1_PHASE2

  2. Jun 2018 — Jun 2019 [monthly]

    Completed PHASE1_PHASE2

  3. Dec 2017 — Jun 2018 [monthly]

    Completed PHASE1_PHASE2

  4. Feb 2017 — Dec 2017 [monthly]

    Completed PHASE1_PHASE2

  5. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE1_PHASE2

    First recorded

Nov 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Johns Hopkins University Specialized Center for Cell Based Therapy
  • Joshua M Hare
  • National Heart, Lung, and Blood Institute (NHLBI)
  • The Emmes Company, LLC
Data source: University of Miami

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

Study Locations