deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 2-arm NCT01351610

Tolerability and Efficacy of Intravenous Infusion of Autologous MSC_Apceth for the Treatment of Critical Limb Ischemia

Open, Randomized, Mono-Centre, Two-Parallel Group Clinical Phase I/II Trial on the Evaluation of Tolerability and Efficacy of an Intravenous Infusion of Human Bone Marrow Derived Autologous, CD34-Negative Mesenchymal Stem Cells for the Treatment of Critical Limb Ischemia in Patients With Advanced Peripheral Arterial Occlusive Disease Subsequent to Percutaneous Transluminal Angioplasty

Sponsor: Apceth GmbH & Co. KG

Updated 5 times since 2017 Last updated: Dec 14, 2015 Started: Mar 31, 2011 Primary completion: Oct 31, 2014 Completion: Oct 31, 2015
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01351610, this PHASE1/PHASE2 trial focuses on Critical Limb Ischemia and Peripheral Artery Disease and remains completed. Sponsored by Apceth GmbH & Co. KG, it has been updated 5 times since 2011, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

5 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1_PHASE2

  5. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE1_PHASE2

    First recorded

Mar 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Apceth GmbH & Co. KG
Data source: Apceth GmbH & Co. KG

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

Study Locations