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NCT00411840 Clinical Trial

Novel Therapy of PAD by Combined Transplantation of BMCs

Peripheral Arterial Disease Clinical Trial

Official title:
Transplantation of Autologous Mononuclear Bone Marrow Stem Cells in Patients With Peripheral Arterial Disease (TAM-PAD Study)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00411840
Other study ID # TAM-PAD
Secondary ID
Status Recruiting
Phase Phase 1
First received December 13, 2006
Last updated December 13, 2006
Start date July 2004

Study information
Verified date December 2006
Source Heinrich-Heine University, Duesseldorf
Contact Thomas Bartsch, MD
Phone +492118118800
Email bartsch@med.uni-duesseldorf.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

We analyze the effects of combined intramuscular and intraarterial transplantation of BMCs in patients with PAD. BMCs were transplanted into the ischemic limb.

After 2 and 13 months walking distance and perfusion indices were monitored.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- severe limb ischemia

Exclusion Criteria:

- infectious disease

- cancer

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• intraarterial and intramuscular injection of BMCs

Locations
Country Name City State
Germany Heinrich-Heine-University Duesseldorf

Sponsors (1)
Lead Sponsor Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary ABI, walking distance, capillary-venous oxygen saturation, venous occlusion plethysmography
Secondary feasibility
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