Peripheral Arterial Disease Clinical Trial
Official title:
Transplantation of Autologous BM-MNC Processed by ResQ Separator and Conventional Manual Method for Patients With Chronic Limb Ischemia: a Multi-center Randomized Controlled Trial
Using autologous bone marrow mononuclear cells (BM-MNC) to treat patients with chronic limb ischemia has been proved safe and effective. However, processing bone marrow by Ficoll density gradient centrifugation is not only time consuming but also expensive. Manually processing of bone marrow also results in large variation in therapeutic cell quantity and quality which directly leads deviation of safety and efficacy of the cell therapy. This study is aiming to compare an automated bone marrow processing system with a conventional manual method in term of safety and efficacy.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | April 2013 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. fontaine's stage 2-4 or resting ABI <0.7 2. age between 20 and 80 years old 3. sign informed consent, voluntary subjects 4. diagnosis of lower extremity arterial occlusive disease, or diabetic lower limb ischemia, or Buerger's disease Exclusion Criteria: 1. poorly controlled diabetes (HBA1c> 7.0%) and proliferative retinopathy (III-IV stage) 2. malignancy history in the past five years or serum level of tumor markers elevated more than doubled 3. severe heart, liver, kidney, respiratory failure or poor general condition can not tolerate BM-MNC transplantation 4. serious infections (such as cellulitis, osteomyelitis, etc.)or gangrene that a major amputation cannot be avoided 5. aortic or iliac or common femoral artery occlusion 6. pregnant female, or reproductive age female who wants to give birth throughout the course of the study 7. life expectancy less than a year |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Xuan Wu Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Xuanwu Hospital, Beijing | Hebei Medical University, Thermogenesis Corp. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cell treatment-related adverse event | Temperature,Pulse,Respiration,Blood Pressure Routine analysis of blood and urine, Liver function(ALT:alanine aminotransferase,AST:aspartate transferase), Renal function(Blood urea nitrogen,Creatinine;) Function of coagulation(APTT,PT,Fib,TT) ECG(Electrocardiography) local inflammatory response Cell-treatment related death Cell-treatment related unexpected amputation. |
2-wk after bone marrow transplantation | Yes |
Secondary | ulcer size | Measuring ulcer area (cm2) and depth (mm)of limb : For each ulcer , photographically record the area and depth with a ruler in order to calculate the ulcer area in square millimeters. |
Post bone marrow transplantation: 1, 3, 6, 12 months | No |
Secondary | rest pain score. | Scoring the rest pain based on the degree of pain as following five scales): 0 level-0 point: no pain; level-1 point: occasional pain which can be recalled; level-2 points: the pain often but can be tolerated, without or with a little analgesics; level-3 points: often with need of general analgesics; level -4 points: affect sleeping due to the pain, general pain medication being difficult to alleviate. Before transplantation: points; after transplantation: points. |
Post bone marrow transplantation: 1,3, 6, 12 months | No |
Secondary | cold sensation score | based on a sense of cold as following five scales: 0 level-0 point: no cold sensation; level-1 point, or : Accasionally cold feeling; level-2 points: Often with cold feeling; level-3 points: significantly cold feeling. and can be significantly improved when using a local insulation. level-4 points: significantly cold feeling,and can not be significantly improved when using a local insulation. |
Post bone marrow transplantation:,1,3, 6, 12 months | No |
Secondary | claudication distance (m) | Measurement of claudication distance (m): For patients with intermittent claudication, treadmill exercise test (no tilt, speed 3km/hr) is employed to measure claudication distance. | Post bone marrow transplantation:1, 3, 6, 12 months | No |
Secondary | Resting ABI | Measurement of ABI(ankle brachial index, ABI): Measure arterial pressure with a laser Doppler, and then calculate the ankle-brachial index, that is a ratio of ankle arterial blood pressure to brachial arterial blood pressure at rest. |
Post bone marrow transplantation: 1,3, 6, 12 months | No |
Secondary | Resting TcPO2 (mmHg) | Transcutaneous oxygen pressure(TcPO2) should be measured at the same site in the ischemic limb at rest. | Post bone marrow transplantation:1, 3, 6, 12 months | No |
Secondary | Collateral vessel score | Collateral vessel score: Using DSA(Digital subtraction angiography)or CTA(computed tomographic angiography) to score the collateral vessel formation. A mean score is obtained for each ischemic limb by 3 independent interventionists based on the following 4 level score: 0 (no new collateral vessels) 1 (A little new collateral vessels) 2 (moderate new collateral blood vessels) 3 (Rich new collateral vessels) |
Post bone marrow transplantation: 1,3, 6, 12 months | No |
Secondary | Amputation rate | Amputation rate and level is recorded. | Post bone marrow transplantation:1, 3, 6, 12 months | No |
Secondary | Skin microcirculation measurement | using PeriMed "laser-Doppler flowmetry" measure the skin microcirculation on the same site in the ischemic limb at rest. | 1,3,6,12 months post transplantation | No |
Secondary | Resting TBI | Measurement of TBI(Toe Brachial Index): Measure arterial pressure with a laser Doppler, and then calculate Toe Brachial Index, that is a ratio of toe arterial blood pressure to brachial arterial blood pressure. |
Post bone marrow transplantation: 1,3, 6, 12 months | No |
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