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| Sponsors and Collaborators: |
Franziskus-Krankenhaus SRH Klinikum Karlsbad-Langensteinbach Stiftungsklinikum Boppard Krankenhaus der Barmherzigen Brüder Trier |
| Information provided by: | Franziskus-Krankenhaus |
| ClinicalTrials.gov Identifier: | NCT00434616 |
Purpose
Critical limb ischemia is a condition where the blood circulation in the limbs, in most cases the legs, is decreased so that pain and non healing wounds ensue. Mostly, this is a sequel of arteriosclerosis and/or diabetes. If surgical and other methods for the improvement of blood supply for the leg have failed or are not possible, most of these patients will proceed to amputation of the leg.
Bone marrow contains cells which can induce and augment the growth of new, small arteries called collateral arteries. It has been shown in animals and in some case series that the transplantation of a concentrate of the patient's own bone marrow with stem cells into the ischemic limb can improve the blood circulation via the induction of collateral growth. However, it is not known if this bone-marrow stem cell induced collateral growth is sufficient to avoid otherwise necessary amputations.
Therefore, we conduct a study to compare the efficiency of concentrated bone marrow cells injected into the critically ischemic limb compared to a placebo procedure where only saline is injected. We think that the transplantation of autologous bone marrow will reduce the number of necessary leg amputations, reduce pain and induce wound healing. In this investigation, patients with limb threatening ischemia are randomly allocated either to the bone marrow group or to the placebo group. Patients in the bone marrow group will have their bone marrow harvested under sedation, and the bone marrow cells are concentrated. The cell concentrate will then be injected directly into the muscle of the diseased leg. Patients in the placebo group will undergo sedation as well but no bone marrow harvest is done, and saline is injected into the ischemic leg. The procedure will require about 1.5-2 hours, and the subjects will be admitted to a participating vascular Centre. Monthly examinations up to three months after the bone-marrow or placebo procedure are done. After the follow-up of three months, the rate of death and amputations and the wound healing process are compared between groups. Adverse and serious adverse events will be recorded during this time period. Diagnostic studies will be obtained to measure blood flow in the treated leg during the follow up period and include skin oxygen measurements, pressure recordings in the leg and arteriography. Also, quality of life, pain and wound healing will be assessed.
After completion of the three months study participation, subjects who have been treated with placebo will be able to receive open-label bone marrow transplantation therapy.
| Condition | Intervention | Phase |
|
Peripheral Vascular Disease Diabetic Foot Peripheral Arterial Occlusive Disease Leg Ulcer Gangrene Ischemia |
Procedure: Autologous bone marrow cell concentrate transplantation Biological: saline injection |
Phase II Phase III |
| MedlinePlus related topics: | Diabetic Foot Foot Health Leg Injuries and Disorders Peripheral Vascular Diseases Vascular Diseases |
| ChemIDplus related topics: | Sodium chloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Security and Effectiveness of Autologous Bone Marrow Stem Cell Transplantation to Avoid Amputations in Patients With Limb-Threatening Ischemia: A Multicentric Randomized Placebo-Controlled Double-Blind Study |
| Estimated Enrollment: | 90 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Placebo Comparator
saline injections
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Biological: saline injection
saline injections
|
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2: Active Comparator
autologous bone marrow transplantation into the ischemic leg
|
Procedure: Autologous bone marrow cell concentrate transplantation
bone marrow aspiration (240 ml), processing and reinjection
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Berthold Amann, MD | 49-30-2638-0 | amann@franziskus-berlin.de |
| Contact: Andre Schmidt-Lucke, MD | 49-30-2638-0 ext 3600 | sl-innere@franziskus-berlin.de |
| Germany | |||||
| Franziskus Hospital Berlin Vascular Center | Recruiting | ||||
| Berlin, Germany, D 10787 | |||||
| Principal Investigator: Berthold Amann, MD | |||||
| Franziskus-Krankenhaus |
| SRH Klinikum Karlsbad-Langensteinbach |
| Stiftungsklinikum Boppard |
| Krankenhaus der Barmherzigen Brüder Trier |
| Principal Investigator: | Berthold Amann, MD | Franziskus Hospital, Berlin Vascular Center |
More Information
Home page of Berlin Vascular Center 
  |
| Responsible Party: | Franziskus-Krankenhaus berlin, germany ( Berthold Amann ) |
| Study ID Numbers: | 2006-001825-24, FKH 200 |
| First Received: | February 9, 2007 |
| Last Updated: | April 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00434616 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
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