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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
Sponsor:
Information provided by:
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00411840
First received: December 13, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • severe limb ischemia

Exclusion Criteria:

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

Contacts
Contact: Thomas Bartsch, MD +492118118800 bartsch@med.uni-duesseldorf.de

Locations
Germany
Heinrich-Heine-University Recruiting
Duesseldorf, Germany, 40225
Contact: Bodo E Strauer, MD     +492118118801     strauer@med.uni-duesseldorf.de    
Principal Investigator: Thomas Bartsch, MD            
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Study Director: Bodo E Strauer, MD Heinrich-Heine University, Duesseldorf
  More Information

No publications provided

ClinicalTrials.gov 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
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013