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Novel Therapy of PAD by Combined Transplantation of BMCs

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by Heinrich-Heine University, Duesseldorf.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00411840
First Posted: December 15, 2006
Last Update Posted: December 15, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Heinrich-Heine University, Duesseldorf
  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
Intervention Model: Single Group Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • severe limb ischemia

Exclusion Criteria:

  • infectious disease
  • cancer
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00411840     History of Changes
Other Study ID Numbers: TAM-PAD
First Submitted: December 13, 2006
First Posted: December 15, 2006
Last Update Posted: December 15, 2006
Last Verified: December 2006

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