Clinical trial NCT02915796: Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty
Official title: Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty: A Randomized Controlled Clinical Trial in Diabetic Patients With Below the Knee Critical Limb Ischemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Peripheral Arterial Disease
Keywords: Endothelial progenitor cell
Percutaneous transluminal angioplasty
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of the present study was to evaluate the therapeutic potential and safety of transarterial infusion of granulocyte colony stimulating factor (G-CSF) mobilized cluster of differentiation (CD) 133(+) cells when combined with percutaneous transluminal angioplasty (PTA) in treatment of below the knee (BTK) peripheral arterial disease (PAD) in diabetic patients.

Detailed description: CD133+ cell, a bone marrow derived subpopulation of adult hematopoietic progenitor cells, confers high proliferative, vasculogenic and regenerative capacity in vitro and in vivo. thereby suggesting that CD133+ cells may induce vasculogenesis, improve limb perfusion, prevent tissue loss and restore ambulatory function in patients with critical limb ischemia. Although several small, randomized trials have been conducted so far demonstrating safety of autologous cells of bone marrow origin for the treatment, the reported benefits were found to be variable. A meta-analysis of autologous bone marrow derived cell therapy for critical limb ischemia trials suggested that application of autologous stem cell transplantation in curing limb ischemic patients does not have obviously effectiveness in the improvement of ankle brachial pressure (ABI) of the limb ischemic patients. But it can dramatically reduce the rate of amputation.

Therefore, in the present study, the investigators aim to evaluate the therapeutic potential and safety of transarterial infusion of g-csf-mobilized CD 133(+) cells when combined with PTA in treatment of below the knee PAD in diabetic patients.

Eligibility criteria: Inclusion Criteria:

1. Age range: 18-75 years , Gender: Both
2. Patients with below the knee limb ischemia with diabetes.
3. Rutherford class 2-6.
4. Target lesions with a diameter reduction of at least 50% and have an occlusion of longer than 4 cm on angiography.
5. Have no previous history of any stem cell therapy \[infusion of CD133 endothelial progenitor cell (EPC)\].

Written informed consent signed by the patients or representatives. -

Exclusion Criteria:

1. Previous bypass surgery or stent placement at the ipsilateral lower limb
2. History of intolerance to antiplatelet therapy, heparin, or contrast media.
3. Presence of any of the following conditions:

   1. severe liver disease (such as ascites, esophageal varices, liver transplantation);
   2. hemodynamic instability;
   3. Severely impaired renal function (serum creatinine level \> 2.5 mg/dL).
   4. Receiving immunosuppressive therapy;
   5. History of decompensated heart failure (New York Heart Association class III or IV and level) or myocardial infarction, or heart bypass surgery;
   6. Bleeding diathesis;
   7. Active systemic bacterial infection;
   8. Acute thrombophlebitis or deep vein thrombosis of the target limb; 4) Pregnant or lactating women, or women of child bearing age unable or unwilling to use effective contraception during the study period; 5) Expected survival time of less than 24 months -

Primary outcomes:
measure: Restenosis rate
timeFrame: 12 months
measure: Peak systolic velocity ratio
timeFrame: 12 months
measure: Severe adverse effects (SAEs)
timeFrame: 12 months
Secondary outcomes:
measure: ABI value
timeFrame: 6 and 12 months
measure: Rutherford classification
timeFrame: 6 and 12 months
measure: Transcutaneous oxygen pressures (TcPO2)
timeFrame: 6 and 12 months
measure: Amputation-free survival (AFS)
timeFrame: 6 and 12 months
measure: Rest pain
timeFrame: 6 and 12 months
measure: Six Minute Walk test
timeFrame: 6 and 12 months
measure: Ulcer healing rate
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital, Tong ji University
Study officials:
References:
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