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Trial record 18 of 67 for:    stem cell peripheral arterial disease AND Occlusive

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
Sponsor:
Collaborators:
Klinikum Karlsbad-Langensteinbach
Stiftungsklinikum Boppard
Krankenhaus der Barmherzigen Brüder Trier
Information provided by:
Franziskus-Krankenhaus

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Placebo Comparator: 1
saline injections
Biological: saline injection
saline injections

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




Primary Outcome Measures :
  1. Major amputation of the index limb or persisting, unchanged critical limb ischemia [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Wound healing (wound size, wound stage) [ Time Frame: 3 months ]
  2. Pain and analgesics use [ Time Frame: 3 months ]
  3. Rutherford grade and stage [ Time Frame: 3 months ]
  4. Walking distance (treadmill) if possible [ Time Frame: 3 months ]
  5. Quality of life (EQ-5D Questionnaire) [ Time Frame: 3 months ]
  6. Transcutaneous oxygen pressure (TcpO2), ABI, absolute ankle perfusion pressure [ Time Frame: 3 months ]
  7. Collateral artery number as judged by contrast angiography after 3 months [ Time Frame: 3 months ]
  8. Rate and extent of minor (below the ankle) amputations [ Time Frame: 3 months ]
  9. survival without amputation [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of Critical Limb ischemia according to the guidelines of the Transatlantic Consensus Group (TASC) Rutherford grade II or III. Perfusion is measured with absolute perfusion pressure and ankle-brachial index (ABI) and transcutaneous oxygen tension (TcpO2); for inclusion, ABI has to be less than or equal to 0.6 or absolute ankle pressure must be less than 60 mmHg. If ABI is technically not feasible, e.g. in patients with media calcification, inclusion criteria are a tcpO2 value (supine, forefoot, 44°C) of less than 20 mmHg if there is no tissue loss, or a tcpO2 of less than 40 mmHg if there is tissue loss.
  • No sufficient response to best standard care delivered for six weeks.
  • No surgical or radiological interventional option for revascularisation as confirmed by a vascular surgeon and an interventional radiologist
  • Age older than 18 years
  • Signed informed consent
  • Absence of life-threatening complications from the ischemic limb

Exclusion Criteria:

  • Expected life span less than six months
  • Bone marrow diseases which preclude transplantation (eg lymphoma, leukaemia, myelodysplastic syndrome and others)
  • Renal failure on hemodialysis
  • Life threatening complications of limb ischemia with the need for immediate limb amputation to avoid death or clinical deterioration

Information from the National Library of Medicine

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


Locations
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Germany
Franziskus Hospital Berlin Vascular Center
Berlin, Germany, D 10787
Sponsors and Collaborators
Franziskus-Krankenhaus
Klinikum Karlsbad-Langensteinbach
Stiftungsklinikum Boppard
Krankenhaus der Barmherzigen Brüder Trier
Investigators
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Principal Investigator: Berthold Amann, MD Franziskus Hospital, Berlin Vascular Center

Additional Information:
Publications:

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Responsible Party: Berthold Amann, Franziskus-Krankenhaus berlin, germany
ClinicalTrials.gov Identifier: NCT00434616     History of Changes
Other Study ID Numbers: 2006-001825-24
FKH 200
First Posted: February 13, 2007    Key Record Dates
Last Update Posted: April 6, 2011
Last Verified: April 2011
Keywords provided by Franziskus-Krankenhaus:
angiogenesis
Arterial Occlusive Diseases
Leg Ulcer
Gangrene
Ischemia
PAOD
Amputation
bone marrow
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Arterial Occlusive Diseases
Pathologic Processes
Cardiovascular Diseases
Skin Diseases
Endocrine System Diseases
Diabetic Foot
Leg Ulcer
Ischemia
Gangrene
Diabetic Angiopathies
Foot Ulcer
Skin Ulcer
Diabetes Complications
Diabetes Mellitus
Diabetic Neuropathies
Atherosclerosis
Arteriosclerosis
Necrosis