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Published on: December 27, 2014
Efficacy of autologous bone marrow mononuclear cell therapy in patients with peripheral arterial disease
Zheng-Xu Wang1, Duo Li, Jun-Xia Cao
1Biotherapy Center, the General Hospital of Beijing Military Command.
Insights
Autologous bone marrow stem cell therapy shows significant benefits for peripheral arterial disease patients, improving limb salvage and reducing pain. This therapy offers a promising alternative for those ineligible for revascularization.
Area of Science:
- Regenerative Medicine
- Vascular Surgery
- Cell Therapy
Background:
- Peripheral arterial disease (PAD), especially critical limb ischemia (CLI), leads to high rates of amputation and mortality, particularly in diabetic patients.
- Current treatment options for CLI are limited, highlighting the need for novel therapeutic approaches.
- Stem cell therapy presents a potential new avenue for treating CLI and improving patient outcomes.
Purpose of the Study:
- To evaluate the efficacy of autologous bone marrow cell therapy in patients with critical limb ischemia (CLI) through a meta-analysis.
- To assess the impact of stem cell therapy on objective clinical endpoints in severe PAD patients.
- To determine the potential of bone marrow stem cells as a therapeutic option for CLI.
Main Methods:
- A comprehensive literature search was conducted across PubMed, Cochrane, Elsevier, and EBSCO databases for relevant trials published before October 30, 2013.
- The meta-analysis included objective clinical endpoints such as ankle-brachial index (ABI), transcutaneous oxygen tension (TcO2), pain reduction, and amputation-free survival (AFS).
- Trials were categorized into randomized controlled trials (RCTs) and non-randomized controlled trials (non-RCTs) for comparative analysis.
Main Results:
- Autologous bone marrow stem cell therapy led to significant increases in ABI at 12, 24, and 48 weeks post-treatment in both RCT and non-RCT groups.
- Transcutaneous oxygen tension (TcO2) showed significant improvements in RCT and non-RCT groups at various time points.
- Pain scores were significantly reduced, and amputation-free survival (AFS) rates improved substantially at one and three years post-therapy.
Conclusions:
- Autologous bone marrow stem cells demonstrate a beneficial therapeutic effect in patients with peripheral arterial disease (PAD) who are not candidates for revascularization.
- Stem cell therapy offers a promising alternative for improving limb salvage and quality of life in CLI patients.
- The findings support the use of bone marrow stem cells as an effective treatment strategy for severe PAD and CLI.
Aim:
Peripheral arterial disease (PAD), particularly critical limb ischemia (CLI), is a severe cause of amputation and mortality. More than 50% of diabetic patients with CLI die within four to five years. The development of novel stem cell therapies may bring new hope to these patients. We aimed to assess the efficacy of autologous bone marrow cell therapy for treating CLI using a meta-analysis.
Methods:
We searched the literature in PubMed, the Cochrane Central Registry of Controlled Trials, the Elsevier database and EBSCO for trials of autologous cell therapy in patients with severe PAD published before October 30, 2013. We chose objective clinical endpoints to assess the efficacy of therapy in the meta-analysis, including changes in the ankle-brachial index (ABI), transcutaneous oxygen tension (TcO2), pain scale (0-10 scale) and amputation-free survival (AFS).
Results:
Thirty-one articles reporting clinical trials involving a total of 1,214 patients treated with bone marrow stem cell-based therapy were collected for the meta-analysis, in which the randomized controlled trials (RCTs) and other trials (non-RCTs) were classified into two groups. Regarding the efficacy of stem cell therapy, the ABI showed significant increases (P＜0.05) at 12 , 24 and 48 weeks after therapy in the non-RCT and RCT groups, but not after four to eight weeks in the non-RCT group. The TcO2 values also increased in the RCT group at four to eight weeks after therapy and 24 weeks after therapy (P＜0.001) and in the non-RCT group at four to eight weeks after therapy (P= 0.01), although no significant increases were observed in the RCT group at 12 weeks after therapy or the non-RCT group at 24 weeks after therapy. Meanwhile, pain was significantly reduced (P＜0.05) at four to eight weeks and 24 weeks after therapy in both the non-RCT and RCT groups, but not at four to eight weeks or 12 weeks after therapy in the RCT group. In addition, the long-term clinical trials demonstrated that the AFS rate improved after therapy with bone marrow stem cells (one-year AFS, P＜0.00001; three-year AFS, P=0.0003).
Conclusions:
The present results suggest that autologous bone marrow stem cells have an advantageous therapy effect in PAD patients who are not eligible for revascularization.
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