Novel Therapy of PAD by Combined Transplantation of BMCs | NCT00411840

Studies
Novel Therapy of PAD by Combined Transplantation of BMCs

NCT00411840

Sponsor

Heinrich-Heine University, Duesseldorf

Status

Unknown status

Last Update Posted

Dec 15, 2006Estimated

Enrollment

100

Phase

Phase 1

Conditions

Peripheral Arterial Disease

Interventions

intraarterial and intramuscular injection of BMCs

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 13, 2006

First Submission Date that Met QC Criteria

Dec 13, 2006

First Posted Date

Dec 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2006

Last Update Posted Date

Dec 15, 2006Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Name	Type	Description	Arm Group Labels	Other Names
intraarterial and intramuscular injection of BMCs	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ABI, walking distance, capillary-venous oxygen saturation, venous occlusion plethysmography

Secondary Outcomes

Measure	Description	Time Frame
feasibility

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

severe limb ischemia

Exclusion Criteria:

infectious disease
cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thomas Bartsch, MD	Contact	+492118118800		bartsch@med.uni-duesseldorf.de

Overall Officials

Name	Affiliation	Role
Bodo E Strauer, MD	Heinrich-Heine University, Duesseldorf	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Heinrich-Heine-University	Recruiting	Düsseldorf		40225	Germany

Condition Browse Module

MeSH Terms

ID	Term
D058729	Peripheral Arterial Disease

Ancestor Terms

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007261	Infusions, Intra-Arterial

Ancestor Terms

ID	Term
D007263	Infusions, Parenteral
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided