Information for Patients
Stem Cell and Regenerative Medicine Clinical Trials at UW-Madison
Blood Diseases | Heart Diseases
BLOOD DISEASES
A Phase III, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prochymal™ (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Steroid Refractory Acute GVHD
Patient eligibility: Patients with graft versus host disease (GVHD) following bone marrow transplantation that did not respond to treatment with steroids
Background: Graft versus host disease (GVHD) is a medical condition in which the donor cells attack following bone marrow transplantation attack and damage tissues of the recipient. GVHD can cause any of the following problems: a rash with itching or peeling of the skin, stomach pain, weight loss, loss of appetite, problems in liver function with jaundice (yellowing of the skin and whites of your eyes), and diarrhea. Most patients require long-term therapy for treatment of their GVHD symptoms and to suppress the immune system (prevent your donor immune cells from attacking your own tissues). However, these drugs have associated risks and side effects. GVHD can also increase your risk of infection. Because of the risks associated with GVHD and its treatment, an investigational agent, Prochymal™, for the treatment of GVHD will be tested in this study. The active ingredient of Prochymal™ is adult human Mesenchymal Stem Cells (MSCs). These cells have shown, but not proven yet, promise in the treatment of GVHD. Adult MSCs are derived from normal healthy adult volunteer bone marrow donor.
Principal Investigator: Peiman Hematti, MD, pxh@medicine.wisc.edu
Study Coordinator: Teri Mitchell
For more information: (608) 263-8629
A Phase 2 Multicenter, Prospective, Observational, Open Label Study to Evaluate the Safety and Efficacy of AMD3100 Added to a GCSF Mobilization Regimen in Poor Mobilizing Adult Patients who have Previously Failed Stem Cell Collections or Collection Attempts
Patient eligibility: Cancer patients in which all other treatments have not been effective in mobilizing enough peripheral stem cells to collect for bone marrow transplant.
Background: The most common way to mobilize stem cells for collection for autologous blood stem cell transplants for people with cancer is with chemotherapy and growth factors such as GCSF and/or GMCSF or growth factors alone. Sometimes the chemotherapy and growth factors do not help to mobilize stem cells for collection. In these patients an inadequate number of stem cells are available for transplantation. Therefore, in the present trial an investigational drug, AMD3100, along with GCSF will be tested for stem cell mobilization.
Principal Investigator: Peiman Hematti, MD, pxh@medicine.wisc.edu
Study Coordinator: Teri Mitchell
For more information: (608) 263-8629
HEART DISEASES
ACT34-CMI - Endomyocardial Injection of Auto-CD34+ in Subjects with Chronic Myocardial Ischemia.
Patient eligibility: Patients with refractory angina that is unsuitable for revascularization either by angioplasty or bypass surgery Patients must be able to walk on a treadmill and have a cardiac ejection fraction ≥ 25%.
Description: Adult stem cells have shown promise for cardiovascular diseases treatment. CD34+ stem cells may improve new blood vessel growth and increase myocardial perfusion and function in those with severe coronary artery obstruction from atherosclerosis. This study hopes to show that CD34+ stem cells can reduce angina frequency in those where conventional therapy has failed.
Principal Investigator: Amish N. Raval, MD, anr@medicine.wisc.edu
Study Coordinator: Soni Vander Ark RN, cav@clinicaltrials.wisc.edu
For more information: (608) 265-0612