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Utility of Autologous and Allogeneic Cell Therapy for Peripheral Arterial Disease

自体和同种异体细胞疗法在外周动脉疾病中的应用

基本信息

批准号：
9039127
负责人：
KEITH LEONARD MARCH
金额：
$ 51.45万
依托单位：
INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-03-15 至 2019-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9039127
关键词：
Addendum Address Adipocytes Adipose tissue Adverse event Age Allogenic Amputation Area Autologous Blood Circulation Blood Vessels Blood flow Bone Marrow Cardiovascular system Categories Cell Separation Cell Therapy Cell Transplants Cell physiology Cells Cessation of life Characteristics Clinical Clinical Trials Clinics and Hospitals Complement Data Devices Dimensions Disease Double-Blind Method Effectiveness Event Harvest Health Heart Heart Diseases Hospitals Immunocompetent Indiana Injection of therapeutic agent Intermittent Claudication Investigational New Drug Application Ischemia Leg Life Limb Salvage Limb structure Lower Extremity Measures Medical center Mononuclear Multicenter Trials Muscle Myocardial Pain Patients Performance Perfusion Peripheral arterial disease Phase Phase III Clinical Trials Placebo Control Placebos Population Principal Investigator Protocols documentation Randomized Rest Risk Safety Single-Blind Study Source Staging Stem cells Stromal Cells Suction Lipectomy Syndrome System Testing Therapeutic Studies Therapy trial Time Tissues Training Ulcer Umbilical Cord Blood Universities Veterans Work base comparative efficacy cost cytokine design disability efficacy testing experience high risk improved indexing novel novel therapeutics pre-clinical programs randomized placebo controlled trial regenerative safety testing

项目摘要

DESCRIPTION (provided by applicant): The Indiana Regional Cardiovascular Cell Therapy Center (IRCCTC) will extend the work of the Cardiovascular Cell Therapy Research Network, particularly in the area of peripheral arterial disease (PAD). Critical limb ischemia (CLI) results in at least 50,000 amputations annually, with a cost estimated at $4.3 billion/year. In a recent Phase l/ll trial we have demonstrated safety and feasibility of intra-muscular injection of autologous bone marrow mononuclear cells (ABMNC) in patients with CLI, and provided initial evidence that this treatment improves amputation-free survival at one year. Although these results are promising, there is an opportunity to improve the effectiveness of cell therapy for CLI by identifying more potent sources of progenitor cells and by evaluating functional characteristics of transplanted cells. While many cardiovascular cell-based trials have focused on ABMNC, adipose stromal cells (ASCs) have demonstrated qualities particularly suitable for promoting limb salvage in CLI. In addition, cord blood mononuclear cells (CBMNC) have been shown to include vasculogenic endothelial progenitor cells, to augment perfusion in ischemic limbs, and to be tolerated by an immunocompetent host. CLI presents an excellent opportunity to examine these two readily accessible cell populations with regard to suitability for cardiovascular cell therapy, in that there exist no other options fo salvage of the index limb, potential adverse events are not immediately life-threatening, and tissue can be obtained for analysis in the event of amputation. Also, mechanisms promoting limb salvage in CLI have relevance to myocardial ischemic syndromes. In this application for a new Regional Center, we propose two protocols, respectively evaluating allogeneic cord blood mononuclear cells and adipose stromal cells as potential therapies for CLI. Aim 1 will evaluate whether CBMNC are superior to placebo in promoting amputation-free survival at 1 year in subjects with critical limb ischemia of Rutherford Category 4, and no /high-risk options for standard revascularization. Aim 2 will test the hypothesis that adipose stromal cells (ASCs) are safe and may increase time to amputation in subjects with critical limb ischemia and ulcers / tissue loss (Rutherford Category 5-6).

描述（由申请人提供）：