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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014