Autologous Bone Marrow Stem Cell Transplantation for Critical, Limb-threatening Ischemia (BONMOT)
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|ClinicalTrials.gov Identifier: NCT00434616|
Recruitment Status : Unknown
Verified April 2011 by Franziskus-Krankenhaus.
Recruitment status was: Active, not recruiting
First Posted : February 13, 2007
Last Update Posted : April 6, 2011
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 or disease||Intervention/treatment||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 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||April 2011|
|Estimated Study Completion Date :||July 2011|
Placebo Comparator: 1
Biological: saline injection
Active Comparator: 2
autologous bone marrow transplantation into the ischemic leg
Procedure: Autologous bone marrow cell concentrate transplantation
bone marrow aspiration (240 ml), processing and reinjection
- Major amputation of the index limb or persisting, unchanged critical limb ischemia [ Time Frame: 3 months ]
- Wound healing (wound size, wound stage) [ Time Frame: 3 months ]
- Pain and analgesics use [ Time Frame: 3 months ]
- Rutherford grade and stage [ Time Frame: 3 months ]
- Walking distance (treadmill) if possible [ Time Frame: 3 months ]
- Quality of life (EQ-5D Questionnaire) [ Time Frame: 3 months ]
- Transcutaneous oxygen pressure (TcpO2), ABI, absolute ankle perfusion pressure [ Time Frame: 3 months ]
- Collateral artery number as judged by contrast angiography after 3 months [ Time Frame: 3 months ]
- Rate and extent of minor (below the ankle) amputations [ Time Frame: 3 months ]
- survival without amputation [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00434616
|Franziskus Hospital Berlin Vascular Center|
|Berlin, Germany, D 10787|
|Principal Investigator:||Berthold Amann, MD||Franziskus Hospital, Berlin Vascular Center|