Peripheral Vascular Disease

Stem cells from bone marrow, cord blood, fat and from blood vessels are being investigated as possible treatments for peripheral vascular disease. Click on the link provided to find out more about each trial. It remains too early to know which approach will be most suitable. We need evidence collected in clinical trials to determine if a proposed stem cell treatment is both safe and effective.

tagged as Peripheral Vascular Disease

  • Phase I/II Trial of Endometrial Regenerative Cells in Patients With Critical Limb Ischemia Location: US
    Overview: This trial at the Indiana University School of Medicine in Indianapolis aims to explore the role of donated mesenchymal stem cells on patients with peripheral vascular disease. The stem cells (otherwise known as Endometrial Regenerative Cells) will be collected from menstrual blood and injected into the muscles of participants who are not eligible for surgical or other interventions (such as percutaneous revascularisation). The subjects will be given three injections into the calf of the affected limb. Participants will be assessed at regular intervals during the following year for complications and for indicators of improved blood flow such as improvements in rest pain and ulcer status. The trial expects to recruit 50 patients between May 2012 and June 2013.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Not yet started
    Stem Cell: Stem Cells (unspecified)
  • Autologous Angiogenic Cell Precursors for the Treatment of Peripheral Artery Disease Location: Hungary
    Overview: This trial evaluated the ability of the patient’s own blood vessel forming stem cells (angiogenic cell precursors – ACPs) to regenerate arteries in patients with peripheral arterial disease. The study was conducted by the Semmelweis University Department of Cardiovascular Surgery and the Kelen Hospital in Budapest in conjunction with TheraVitae Ltd. Participants in the study were at high risk of amputation of the affected limb and enrolled into the control or treatment arms of the study. Those in the control arm received only conventional treatment. Those in the treatment arm received into the muscles of the affected limb. All participants were monitored for changes in vascular function. The trial recruited 22 patients between May 2008 and April 2009 and was completed in July 2009. It is not clear whether the results of this study have been published.
    Link to Clinical Registry
    Trial Design: Therapeutic intervention
    Status: Completed
    Stem Cell: Stem Cells (unspecified)
  • Clinical Trial Phase I/II Multicentric, Open, Randomized and Controlled for the Study of Stem Cells as Therapy Critical Ischemia in Low Limbs in Insulinized Type 2 Diabetic Patients Location: Spain
    Overview: This trial is investigating the effects of patient's own stem cells as therapy for critical ischemia in lower limbs in patients with type 2 diabetics. The trial is being conducted by the Fundación progreso y Salud in Seville and seeks to compare the effects of injecting different stem cells as therapy for critical ischemia in lower limbs in type 2 diabetic patients. Participants must have non-healing ulcers older than four weeks and no potential for conventional treatment (eg revascularisation). Participants will be randomly allocated into groups receiving randomised to receiving either their own bone marrow stem cells; mesenchymal stem cells from their fat, or their own selected bone marrow stem cells (CD 133+ stem cells). The cells will be delivered directly into the artery of the affected limb. Participants will be monitored for complications and assessed for changes in their clinical condition. The study commenced in July 2011 and expects to enrol 48 patients.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Adult Bone Marrow Stem Cells
  • Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cells Implantation in Patients with Critical Limb Ischemia Location: South Korea
    Overview: This trial was conducted at the Pusan National University Hospital, Pusan Korea in conjunction with RNL bio Co Ltd from January 2009 to April 2011. 20 subjects suffering from Peripheral Vascular Disease with Critical Limb Ischaemia were given intramuscular injections of autologous adipose derived stem cells. Major adverse events were recorded at baseline, 3, 6 & 12 months after the injection as the primary outcome. Ankle Brachial Index, Digital Subtraction Angiography, Treadmill Test and visual analogue pain scores were recorded at the same intervals as the secondary outcome.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Completed
    Stem Cell: Adult Fatty Tissue Stem Cells
  • Safety and Efficacy of Allogeneic Cells for the Treatment of Intermittent Claudication Location: US
    Overview: This trial aims to investigate the use of a proprietary mesenchymal stem cell product in the treatment of advanced peripheral arterial disease. The trial is being conducted in 15 centres in 12 US states and four centres in Germany by a biotech company Pluristem Ltd. Pluristem has developed a proprietary product called PLX PAD composed of mesenchymal stem cells obtained from human placenta. The trial expects to enrol 150 patients suffering from peripheral artery disease with intermittent claudication by December 2015. Participants will be randomly divided to one of four groups. The first group will receive two low-dose injections of the cells. The second will receive two high-dose injections of the cells. The third group will receive one injection of high-dose cells and one placebo injection. The final group will receive two placebo. Participants will be monitored for complications and improvements in their condition. Pluristem Ltd is conducting a similar global trial for Critical Limb Ischaemia resulting from advanced peripheral arterial disease.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Umbilical Cord Stem Cells
  • Application of Cell Regeneration Therapy With Mesenchymal Stem Cells From Adipose Tissue in Critical Chronic Ischemic Syndrome of Lower Limbs in Nondiabetic Patients. Location: Spain
    Overview: This trial aims to investigate the use of stem cells obtained from the patient's fat in treating Critical Limb Ischaemia. The trial is sponsored by the Fundación Pública Andaluza Progreso y Salud, in conjunction with Iniciativa Andaluza en Terapias Avanzadas, and proposes to recruit 33 patients between February 2011 and July 2013. Participants will be treated at the University Hospital and the Hospital San Lazaro in Seville. Participants will be randomly divided into three groups. The control group will receive a placebo injection. The two experimental groups will receive different doses of their own stem cells. All participants will be monitored for up to one year for complications following the transfusion, and changes in clinical condition including changes in perfusion and ulceration.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Adult Fatty Tissue Stem Cells
  • Stem Cells for Peripheral Vascular Disease Location: Australia
    Overview: This trial aims to compare the effect of the patient's own blood stem in treating patients with severe peripheral arterial disease. The trial is being conducted at the Alfred Hospital in Melbourne and proposes to recruit 20 subjects. The subjects will be randomly assigned to two groups. They will either receive a single injection of CD 34+ stem cells via the limb artery (experimental group) or a placebo injection (control group). Participants will be monitored for complications and assessed for changes in their clinical condition.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Not yet started
    Stem Cell: Adult Bone Marrow Stem Cells