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Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial *

Background

Preclinical studies have established that implantation of bone marrow-mononuclear cells, including endothelial progenitor cells, into ischaemic limbs increases collateral vessel formation. We investigated efficacy and safety of autologous implantation of bone marrow-mononuclear cells in patients with ischaemic limbs because of peripheral arterial disease.

Methods

We first did a pilot study, in which 25 patients (group A) with unilateral ischaemia of the leg were injected with bone marrow-mononuclear cells into the gastrocnemius of the ischaemic limb and with saline into the less ischaemic limb. We then recruited 22 patients (group B) with bilateral leg ischaemia, who were randomly injected with bone marrowmononuclear cells in one leg and peripheral blood-mononuclear cells in the other as a control. Primary outcomes were safety and feasibility of treatment, based on ankle-brachial index (ABI) and rest pain, and analysis was per protocol.

Findings

Two patients were excluded from group B after randomisation. At 4 weeks in group B patients, ABI was significantly improved in legs injected with bone marrowmononuclear cells compared with those injected with peripheral blood-mononuclear cells (difference 0·09 [95% CI 0·06–0·11]; p<0·0001). Similar improvements were seen for transcutaneous oxygen pressure (13 [9–17]; p<0·0001), rest pain (-0·85 [-1·6 to -0·12]; p=0·025), and pain-free walking time (1·2 [0·7–1·7]; p=0·0001). These improvements were sustained at 24 weeks. Similar improvements were seen in group A patients. Two patients in group A died after myocardial infarction unrelated to treatment.

Interpretation

Autologous implantation of bone marrowmononuclear cells could be safe and effective for achievement of therapeutic angiogenesis, because of the natural ability of marrow cells to supply endothelial progenitor cells and to secrete various angiogenic factors or cytokines.

* Legal Disclaimer: Chelation and Hyperbaric Therapy, Stem Cell Therapy, and other treatments and modalities mentioned or referred to in this web site are medical techniques that may or may not be considered “mainstream”. As with any medical treatment, results will vary among individuals, and there is no implication or guarantee that you will heal or achieve the same outcome as patients herein.

As with any procedure, there could be pain or other substantial risks involved. These concerns should be discussed with your health care provider prior to any treatment so that you have proper informed consent and understand that there are no guarantees to healing.

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Published on 02-20-2018
Authors: Eriko Tateishi-Yuyama,Hiroaki Matsubara, Toyoaki Murohara, Uichi Ikeda, Satoshi Shintani, Hiroya Masaki, Katsuya Amano, Yuji Kishimoto, Kohji Yoshimoto, Hidetoshi Akashi, Kazuyuki Shimada, Toshiji Iwasaka, Tsutomu Imaizumi