NCT00411840

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2006

Completed
Last Updated

December 15, 2006

Status Verified

December 1, 2006

First QC Date

December 13, 2006

Last Update Submit

December 13, 2006

Conditions

Peripheral Arterial Disease

Keywords

stem cell therapyperipheral arterial diseaselimb ischemia

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • feasibility

Interventions

intraarterial and intramuscular injection of BMCsPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • severe limb ischemia

You may not qualify if:

  • infectious disease
  • cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heinrich-Heine-University

Düsseldorf, 40225, Germany

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Infusions, Intra-Arterial

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Infusions, ParenteralDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Bodo E Strauer, MD

    Heinrich-Heine University, Duesseldorf

    STUDY DIRECTOR

Central Study Contacts

Thomas Bartsch, MD

CONTACT

+492118118800bartsch@med.uni-duesseldorf.de

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2006

First Posted

December 15, 2006

Study Start

July 1, 2004

Last Updated

December 15, 2006

Record last verified: 2006-12

Locations

DE(1)