Autologous CD34+cell transplantation promotes angiogenesis in older adult patients with atherosclerotic ischemia:study protocol for a prospective, single-center, open-label, randomized controlled clinical trial
10.3969/j.issn.2095-4344.2017.13.006
- VernacularTitle:外周血CD34+细胞自体移植促进老年动脉粥样性缺血肢体的血管新生:前瞻性、单中心、开放性、随机对照临床试验方案
- Author:
Chenhong ZHOU
;
Lili XU
;
Xiuxian HAO
;
Xiaojuan SUN
;
Mingjin GUO
;
Bing LIU
- From:
Chinese Journal of Tissue Engineering Research
2017;21(13):1998-2002
- CountryChina
- Language:Chinese
-
Abstract:
BACKGROUND:The main clinical manifestation of senile arteriosclerosis obliterans is lower limb ischemia, which is currently difficult to treat. One method is by 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.OBJECTIVE:To assume that peripheral blood autologous CD34+ cell transplantation in the elderly with atherosclerotic ischemia could effectively promote angiogenesis.METHODS:This is a prospective, single-center, open-label, randomized, and controlled clinical trial that will be completed 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 intramuscularly transplanted into the ischemic limbs in older adult patients with atherosclerotic lower limb ischemia. In the control group (n=10), normal saline will be intramuscularly injected into the ischemic limbs. All 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. The trial was registered at the ClinicalTrials.gov (identifier:NCT03098771), and the study protocol was approved by the Ethics Committee of Qingdao No. 9 People's Hospital of China. All protocols will be in accordance with Declaration of Helsinki,formulated by the World Medical Association. All patients will be informed of study protocols and provide a written informed consent prior to the beginning of the trial.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.
