Information for Patients
Stem Cell and Regenerative Medicine Clinical Trials at UW-Madison
HEART DISEASES
SCRIPT-CLI
is a study for people who have severe Peripheral Artery Disease (PAD), a condition where leg arteries are blocked causing pain, skin ulcers and infection due to poor blood flow. The study is accepting people who have been told that the blood flow can’t be restored by surgical procedures, either because of small arteries or other medical conditions or may require amputation. The study is testing the safety and potential benefit of injecting a person’s own stem cells (CD133+) into the leg muscles. These stem cells are collected from the blood after 5 daily injections that stimulate the body to produce the stem cells. The hope is that this treatment will improve blood flow to the legs, heal wounds, and decrease leg pain. (Stem cell revascularization in patients with Critical Limb Ischemia).
Osiris protocol 403
is a 2 year study to treat heart damage resulting from a heart attack. The purpose of this study is to test the safety and potential benefit of Prochymal®, an adult stem cell product, for the treatment of heart damage that resulted from a person’s first heart attack. These adult stem cells come from bone marrow of healthy people. Prochymal® is given intravenously one time within the first 7 days of a heart attack. It is expected that Prochymal® will repair the heart damage and prevent future heart related problems by reducing inflammation in the heart muscle.
(A Phase II, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Prochymal® (ex vivo cultured adult human mesenchymal stem cells) intravenous infusion following acute myocardial infarction).
ACT 34 CMI
is a study for people with severe angina (chest pain) that isn’t relieved using standard medical treatments. Angina is the result of reduced blood flow and oxygen to the heart muscle because of blood vessel blockage. This study will test the safety and potential benefit of injecting a person’s own stem cells (CD34+ cells) directly into the heart muscle using a special catheter. Stem cells are collected from the blood after 5 daily injections that stimulate the body to produce these stem cells. Early results of this study show that people who got the stem cell injection, experienced less chest pain and an improvement in their quality of life.
(A double blind, prospective, randomized, placebo-controlled study to determine the tolerability, efficacy, safety and dose range of intramyocardial injections of G-CSF mobilized Auto-CD34+ cells for reduction of angina episodes in subjects with refractory chronic myocardial ischemia).
CUPID
is a study for people who have moderate to severe heart failure. This study tests different doses of Mydicar® a gene-targeted enzyme therapy as a single infusion into the blood vessels of the heart using a special catheter. The purpose of the study is to find out what dose of Mydicar® is safe and beneficial for improving symptoms of heart failure.
The early results of this study show that Mydicar® infusion was helpful in lessening the progression of heart failure. (Calcium Up-Regulation by Percutaneous Administration of Gene Therapy In Cardiac Disease).
Principal Investigator: Amish N. Raval, MD, anr@medicine.wisc.edu
Study Coordinator: Cathlyn Leitzke RN, cjl@medicine.wisc.edu or Cassondra (Soni) Vander Ark RN cav@clinicaltrials.wisc.edu
For more information: 608-262-2290 or 608-265-0612