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Novel Therapy of PAD by Combined Transplantation of BMCs

Primary Purpose

Peripheral Arterial Disease

Status

Unknown status

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

intraarterial and intramuscular injection of BMCs

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring stem cell therapy, peripheral arterial disease, limb ischemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

severe limb ischemia

Exclusion Criteria:

infectious disease
cancer

Sites / Locations

Heinrich-Heine-UniversityRecruiting

Outcomes

Primary Outcome Measures

ABI, walking distance, capillary-venous oxygen saturation, venous occlusion plethysmography

Secondary Outcome Measures

feasibility

Full Information

NCT ID

NCT00411840

First Posted

December 13, 2006

Last Updated

December 13, 2006

Sponsor

Heinrich-Heine University, Duesseldorf

1. Study Identification

Unique Protocol Identification Number

NCT00411840

Brief Title

Novel Therapy of PAD by Combined Transplantation of BMCs

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2006

Overall Recruitment Status

Unknown status

Study Start Date

July 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Heinrich-Heine University, Duesseldorf

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease

Keywords

stem cell therapy, peripheral arterial disease, limb ischemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

intraarterial and intramuscular injection of BMCs

Primary Outcome Measure Information:

Title

ABI, walking distance, capillary-venous oxygen saturation, venous occlusion plethysmography

Secondary Outcome Measure Information:

Title

feasibility

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: severe limb ischemia Exclusion Criteria: infectious disease cancer

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas Bartsch, MD

Phone

+492118118800

bartsch@med.uni-duesseldorf.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bodo E Strauer, MD

Organizational Affiliation

Heinrich-Heine University, Duesseldorf

Official's Role

Study Director

Facility Information:

Facility Name

Heinrich-Heine-University

City

Duesseldorf

ZIP/Postal Code

40225

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bodo E Strauer, MD

Phone

+492118118801

strauer@med.uni-duesseldorf.de

First Name & Middle Initial & Last Name & Degree

Thomas Bartsch, MD

12. IPD Sharing Statement

Learn more about this trial

Novel Therapy of PAD by Combined Transplantation of BMCs

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