Novel Therapy of PAD by Combined Transplantation of BMCs

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Heinrich-Heine University, Duesseldorf.
Recruitment status was  Recruiting
Information provided by:
Heinrich-Heine University, Duesseldorf Identifier:
First received: December 13, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted

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.

Condition Intervention Phase
Peripheral Arterial Disease
Procedure: intraarterial and intramuscular injection of BMCs
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transplantation of Autologous Mononuclear Bone Marrow Stem Cells in Patients With Peripheral Arterial Disease (TAM-PAD Study)

Resource links provided by NLM:

Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • ABI, walking distance, capillary-venous oxygen saturation, venous occlusion plethysmography

Secondary Outcome Measures:
  • feasibility

Estimated Enrollment: 100
Study Start Date: July 2004

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • severe limb ischemia

Exclusion Criteria:

  • infectious disease
  • cancer
  Contacts and Locations
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Please refer to this study by its identifier: NCT00411840

Contact: Thomas Bartsch, MD +492118118800

Heinrich-Heine-University Recruiting
Duesseldorf, Germany, 40225
Contact: Bodo E Strauer, MD    +492118118801   
Principal Investigator: Thomas Bartsch, MD         
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Study Director: Bodo E Strauer, MD Heinrich-Heine University, Duesseldorf
  More Information Identifier: NCT00411840     History of Changes
Other Study ID Numbers: TAM-PAD 
Study First Received: December 13, 2006
Last Updated: December 13, 2006
Health Authority: Germany: Ethics Commission

Keywords provided by Heinrich-Heine University, Duesseldorf:
stem cell therapy
peripheral arterial disease
limb ischemia

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on May 26, 2016