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

NCT01351610 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-12-15

No results posted yet for this study

Summary

MSC\_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow derived stem cells for the treatment of Critical Limb Ischemia

Conditions

Interventions

BIOLOGICAL

PTA + Infusion of MSC_Apceth

percutaneous transluminal angioplasty followed by infusion of MSC\_Apceth

PROCEDURE

PTA

percutaneous transluminal angioplasty only

Sponsors & Collaborators

  • Apceth GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Peter Heider, MD, PhD · Isar Medizin Zentrum, München

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-10-31
Completion
2015-10-31

Countries

  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01351610 on ClinicalTrials.gov