Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia (ABC)
Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia A Double Blind, Placebo Controlled, Study in Diabetic and Non-diabetic Patients
연구 개요
상세 설명
Although the safety and beneficial effects of intramuscular transplantation of bone marrow derived mononuclear cells procedure appear well documented, a number of critical question regarding application of BM-MNC for peripheral vascular disease remain to be answered. First, although the original study has been partially performed as semi-blinded study (patients with double sided claudication were recruited and blindly treated with BM-MNC in one leg and peripheral blood injections in the other leg), this approach does exclude a placebo effect. Second, although patients with mild diabetes were included in the protocol, the results for diabetic patients were not analyzed separately. Diabetic disease is characterized by monocyte and endothelial progenitor cell dysfunction and it is still unclear whether this approach is also effective in diabetic patients. Third, although six-month results are reported long-term efficacy has not been established yet.
To address these issues, the investigators now propose confirm and extend the findings from open studies in a randomized double-blind study in patients with severe claudication or critical leg ischemia and pay special attention to the influence of diabetic disease on the outcome of the study and to the possible pro-atherogenic/ pro-inflammatory effects of BM-MNC injections.
연구 유형
등록 (예상)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
-
-
-
Leiden, 네덜란드, 2300RC
- 모병
- Leiden University Medical Center
-
연락하다:
- Jan HN Lindeman, MD, PhD
- 전화번호: #31 (0)71 5263968
- 이메일: Lindeman@lumc.nl
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- persistent (>3 months) disabling claudication (Fontaine's stages IIb or Rutherford's categories 3, viz. pain free walking distance less than 100 meter) despite optimal therapy or critical limb ischemia (Fontaine's stages III/IV or Rutherford's categories 4-6)
- ineligibility for angioplasty or bypass procedures
- male of female, >18 years old
- life expectancy > 1 year
- written informed consent
Exclusion Criteria:
- candidates for angioplasty or bypass procedures
- inability to undergo bone marrow harvesting
- any condition in the affected limb that is anticipated to require surgical intervention in the first weeks after BM-MNC treatment
- life threatening co-morbidity
- poorly controlled diabetes (HbA1C > 10%)
- active malignancy in the 5 years prior to treatment
- INR >1.5 at the time of bone-marrow harvest
- bleeding diathesis
- inability to undergo arterial catheterization
- inability to follow the protocol and to comply with the follow up requirements
- any other conditions that, in the opinion of the investigators, could interfere with the therapy or could pose a significant threat to the subject if the investigational therapy was to be initiated
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 1
non diabetic patients with Fontaine IIb-IV peripheral artery disease
|
40 IM injections (calf muscle) of 1-8 10E9 mono nuclear cells
|
|
위약 비교기: 2
non diabetic patients with Fontaine IIb-IV peripheral artery disease
|
40 IM injections (calf muscle) of placebo suspension
|
|
활성 비교기: 3
diabetic patients with Fontaine IIb-IV peripheral artery disease
|
40 IM injections (calf muscle) of 1-8 10E9 mono nuclear cells
|
|
위약 비교기: 4
diabetic patients with Fontaine IIb-IV peripheral artery disease
|
40 IM injections (calf muscle) of placebo suspension
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Limb salvage/wound healing at t=6 months; Pain free walking distance
기간: 6 months
|
6 months
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
quality of life (RAND-36), pain Scores (Brief Pain Inventory), tcO2 (wrist/ankle ratio) ABI Collateral artery scores (angiogram) at t=6 months, Limb salvage/wound healing at t= 3 and 12 months, Pain free walking distance at t=3 and 12 months,
기간: 3, 6 and 12 months
|
3, 6 and 12 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jan HN Lindeman, MD, PhD, Leiden University Medical Center
간행물 및 유용한 링크
일반 간행물
- Moazzami B, Mohammadpour Z, Zabala ZE, Farokhi E, Roohi A, Dolmatova E, Moazzami K. Local intramuscular transplantation of autologous bone marrow mononuclear cells for critical lower limb ischaemia. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD008347. doi: 10.1002/14651858.CD008347.pub4.
- Lindeman JHN, Zwaginga JJ, Kallenberg-Lantrua G, van Wissen RC, Schepers A, van Bockel HJ, Fibbe WE, Hamming JF. No Clinical Benefit of Intramuscular Delivery of Bone Marrow-derived Mononuclear Cells in Nonreconstructable Peripheral Arterial Disease: Results of a Phase-III Randomized-controlled Trial. Ann Surg. 2018 Nov;268(5):756-761. doi: 10.1097/SLA.0000000000002896.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
말초 혈관 질환에 대한 임상 시험
-
C. R. Bard완전한
-
Mayo Clinic초대로 등록
-
University of Pennsylvania완전한Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410의 주진단 또는 이차진단 코드가 있는 환자(5번째 숫자가 2인 경우 제외)미국