A Phase 1 interventional study of G-CSF + CD133(+) cells and G-CSF in Peripheral Arterial Disease, sponsored by Shanghai 10th People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-09-28.
Sponsored by Shanghai 10th People's Hospital · Phase 1, Interventional, and Treatment
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.
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's planned enrollment of 345 is above the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Shanghai 10th People's Hospital is the lead sponsor of 167 studies on the registry; 45 are open to participants now.
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Written informed consent signed by the patients or representatives. -
Exclusion Criteria:
Presence of any of the following conditions:
Intramuscular injection of G-CSF along with transarterial infusion of CD133 (+) cells combined with percutaneous transluminal angioplasty
Biological: G-CSF + CD133(+) cells · Procedure: percutaneous transluminal angioplasty (PTA)
Percutaneous transluminal angioplasty along with intramuscular injection of G-CSF
Biological: G-CSF · Procedure: percutaneous transluminal angioplasty (PTA)
Only Percutaneous transluminal angioplasty along with placebo infusion of sodium chloride injection
Procedure: percutaneous transluminal angioplasty (PTA) · Biological: Placebo infusion
Patients in the G-CSF + CD133(+) cells + PTA group, received 150 unit of recombinant human G-CSF intramuscular injection to mobilize CD 133 cells from bone marrow to peripheral blood. After 72-120 hrs, 100 ml suspension of peripheral arterial blood were collected and send to Good Products Manufacturing (GPM) certified laboratory (Shanghai Chen Chuan Biological Material Co. Ltd.) within 24 hrs of obtaining sample to isolate CD 133(+) endothelial progenitor cells (EPC) using magnetic cell separator. Subjects in this group, after vascular PTA treatment, received transarterial infusion of 50 ml suspension of isolated autologous CD 133(+) cells over 30 min via catheter opened into popliteal artery. The infusion of CD 133 cells was repeated after 24 hours.
Subjects in this group, after vascular PTA treatment, received 150 unit of recombinant human G-CSF intramuscular injection to mobilize EPCs from bone marrow to peripheral blood. But the C133 (+) cells were not isolated from the peripheral blood to infuse transarterially as in G-CSF + CD133(+) + PTA.
Subjects in this group only underwent below the knee percutaneous transluminal angioplasty .
Neither G-CSF was injected nor CD133(+) cells. Instead, subjects received placebo infusion (50 ml of 0.9% sodium chloride injection ) over 30 min.
Restenosis rate
Occurrence of \> 50% of restenosis in the treated vessel after 12 months as assessed by digital substraction angiography (DSA) (Efficacy endpoints).
Time frame: 12 months
Peak systolic velocity ratio
Peak systolic velocity ratio ≥ 2.4 by Doppler's ultrasonography for patients who did not undergo angiography after 12 months (Efficacy endpoints).
Time frame: 12 months
Severe adverse effects (SAEs)
Number of SAEs per subject across actual treatment cohorts (Safety Endpoint).
Time frame: 12 months
ABI value
Improvement in ABI value by ≥ 0.1 after the procedure and lack of deterioration \> 0.15 in relation to the maximal value recorded before the procedure.
Time frame: 6 and 12 months
Rutherford classification
improvement in Rutherford scale of at least one category after the procedure.
Time frame: 6 and 12 months
Transcutaneous oxygen pressures (TcPO2)
.Changes in TcPO2 was assessed at each follow up interval and compared to baseline.
Time frame: 6 and 12 months
Amputation-free survival (AFS)
Time to below the knee amputation of the ipsilateral leg.
Time frame: 6 and 12 months
Rest pain
Rest pain was measured using Wong-Baker FACES pain rating scale at baseline and each follow-up visit.
Time frame: 6 and 12 months
Six Minute Walk test
Walking distance, time to onset of leg cramping/pain were recorded.
Time frame: 6 and 12 months
Ulcer healing rate
Ulcer status was assessed at each follow up interval and compared to baseline.
Time frame: 6 and 12 months
Plan to share: No
This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Shanghai 10th People's Hospital