Back to resultsSafety and Feasibility Study of Autologous Bone Marrow Cell Transplantation in Patients With Peripheral Arterial Occlusive Disease (PAOD)
Primary Purpose
Arterial Occlusive Diseases
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
intraarterial stem cell therapy
Stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Arterial Occlusive Diseases focused on measuring critical limb ischemia, peripheral arterial occlusive disease, [C14.907.137]
Eligibility Criteria
Inclusion Criteria: Patients with PAOD (Stage III or IV) Distal arterial occlusions Patients with Buergers Disease Signed informed consent Exclusion Criteria: Successful bypass operation or intervention within the last 3 months Active infection, feber, chronic inflammatory disease HIV, Hepatitis Tumor within the last 5 years, complete remission required Stroke or myocardial infarction within last 3 months Renal insufficiency (creatinine > 2 mg/dl) Liver disease (GOT > 2x upper limit oder spontaneous INR > 1,5). Anemia (hemoglobin < <10 mg/dl) Thrombocytopenia < 100.000/µl Allergies to Aspirin, Clopidogrel, Heparin Bleeding disorder Gastrointestinal bleeding within last 3 months Surgery or trauma within the last 2 months Pregnancy Mental retardation Inclusion in other clinical study within last 30 days
Sites / Locations
- Div. of Cardiology and Vascular Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
intraarterial application of bone marrow mononuclear cells
intraarterial application of placebo
Outcomes
Primary Outcome Measures
Ankle brachial index
Secondary Outcome Measures
Ulcer size
Pain
Walking distance
TCO2
Full Information
NCT ID
NCT00282646
First Posted
January 25, 2006
Last Updated
October 18, 2021
Sponsor
Johann Wolfgang Goethe University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00282646
Brief Title
Safety and Feasibility Study of Autologous Bone Marrow Cell Transplantation in Patients With Peripheral Arterial Occlusive Disease (PAOD)
Official Title
(Intraarterial Progenitor Cell Transplantation of Bone Marrow Mononuclear Cells for Induction of Neovascularization in Patients With Peripheral Arterial Occlusive Disease)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with peripheral artery disease, stage III or IV who are not candidates for interventional or operative therapy should be treated with intraarterial progenitor cell therapy (autologous bone marrow cells) in a randomized, placebo controlled trial.
Detailed Description
Main goal:
Improvement of limb perfusion (Ankle brachial index).
Secondary aims:
Reduction of pain Reduction of Ulcer size Walking distance Improvement in tissue oxygenation (TCO2) Minor or major amputation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Occlusive Diseases
Keywords
critical limb ischemia, peripheral arterial occlusive disease, [C14.907.137]
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Intraarterial administration of BM-MNC or placebo
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
intraarterial application of bone marrow mononuclear cells
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
intraarterial application of placebo
Intervention Type
Procedure
Intervention Name(s)
intraarterial stem cell therapy
Intervention Description
catheter delivery of stem cells
Intervention Type
Other
Intervention Name(s)
Stem cells
Intervention Description
intraarterial application of bone marrow mononuclear cells versus placebo
Primary Outcome Measure Information:
Title
Ankle brachial index
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Ulcer size
Time Frame
6 months
Title
Pain
Time Frame
6 months
Title
Walking distance
Time Frame
6 months
Title
TCO2
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with PAOD (Stage III or IV)
Distal arterial occlusions
Patients with Buergers Disease
Signed informed consent
Exclusion Criteria:
Successful bypass operation or intervention within the last 3 months
Active infection, feber, chronic inflammatory disease
HIV, Hepatitis
Tumor within the last 5 years, complete remission required
Stroke or myocardial infarction within last 3 months
Renal insufficiency (creatinine > 2 mg/dl)
Liver disease (GOT > 2x upper limit oder spontaneous INR > 1,5).
Anemia (hemoglobin < <10 mg/dl)
Thrombocytopenia < 100.000/µl
Allergies to Aspirin, Clopidogrel, Heparin
Bleeding disorder
Gastrointestinal bleeding within last 3 months
Surgery or trauma within the last 2 months
Pregnancy
Mental retardation
Inclusion in other clinical study within last 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas M Zeiher, MD
Organizational Affiliation
Div. of Cardiology, University of Frankfurt, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dirk H Walter, MD
Organizational Affiliation
Div. of Cardiology, University of Frankfurt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Div. of Cardiology and Vascular Medicine
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
21586692
Citation
Sciahbasi A, Romagnoli E, Trani C, Burzotta F, Sarandrea A, Summaria F, Patrizi R, Rao S, Lioy E. Operator radiation exposure during percutaneous coronary procedures through the left or right radial approach: the TALENT dosimetric substudy. Circ Cardiovasc Interv. 2011 Jun;4(3):226-31. doi: 10.1161/CIRCINTERVENTIONS.111.961185. Epub 2011 May 17.
Results Reference
derived
PubMed Identifier
21205939
Citation
Walter DH, Krankenberg H, Balzer JO, Kalka C, Baumgartner I, Schluter M, Tonn T, Seeger F, Dimmeler S, Lindhoff-Last E, Zeiher AM; PROVASA Investigators. Intraarterial administration of bone marrow mononuclear cells in patients with critical limb ischemia: a randomized-start, placebo-controlled pilot trial (PROVASA). Circ Cardiovasc Interv. 2011 Feb 1;4(1):26-37. doi: 10.1161/CIRCINTERVENTIONS.110.958348. Epub 2011 Jan 4.
Results Reference
derived
Learn more about this trial
Safety and Feasibility Study of Autologous Bone Marrow Cell Transplantation in Patients With Peripheral Arterial Occlusive Disease (PAOD)
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