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STUDY PROTOCOL
Year : 2017  |  Volume : 2  |  Issue : 1  |  Page : 12-17

Autologous CD34+ cell transplantation promotes angiogenesis in older adult patients with atherosclerotic ischemia: study protocol for a randomized controlled trial


Qingdao No. 9 People's Hospital, Qingdao, Shandong Province, China

Correspondence Address:
Bing Liu
Qingdao No. 9 People's Hospital, Qingdao, Shandong Province
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2542-3975.202724

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Background: The main clinical manifestation of senile arteriosclerosis obliterans is lower limb ischemia, which is currently difficult to treat. One method is autologous stem cell transplantation into the muscles of ischemic limbs to improve the formation of new capillaries and restore lower limb blood flow. Endothelial progenitor cell marker CD34+ cell transplantation has been shown to promote angiogenesis in ischemic limbs. Therefore, we propose that peripheral blood autologous CD34+ cell transplantation in older adult patients with atherosclerotic ischemia could effectively promote angiogenesis. Methods/Design: We propose to conduct a prospective, single-center, open-label, randomized, and controlled clinical trial at the Qingdao No. 9 People's Hospital, China. Twenty older adult patients with atherosclerotic lower limb ischemia will be randomized into two groups. In the cell transplantation group (n = 10), peripheral blood CD34+ cells transfected with vascular endothelial growth factor 165 (VEGF165) gene will be transplanted into the muscles of ischemic limbs in older adult patients with atherosclerotic lower limb ischemia. In the control group (n = 10), physiological saline will be injected into the muscles of ischemic limbs. Patients will be followed up for 6 months. The primary outcome will be ankle-brachial indices before and 6 months after transplantation to assess lower limb ischemia in both groups. The secondary outcomes will be the number of microvessels in the lower limb muscles before and 6 months after transplantation, the morphology of new blood vessels revealed by CT angiography, the number of VEGF-immunoreactive cells 6 months after transplantation and the incidence of adverse reactions. Discussion: This trial will begin in January 2018 and finish in December 2019. We aim to quantify the effects of VEGF165 gene-modified CD34+ cell transplantation in the treatment of older adult patients with atherosclerotic ischemia to develop a new effective treatment of lower limb ischemia. Trial registration: ClinicalTrials.gov identifier: NCT03098771. Ethics: The study protocol has been approved by the Ethics Committee of Qingdao No. 9 People's Hospital of China. All protocols will be in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent will be provided by participants.


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