Stem Cell Transplant Clinical Trials

Stem Cell Transplant Clinical Trials Lead to Knowledge and New Discoveries in the Fight Against Cancer

In addition to standard therapies, University Hospitals Seidman Cancer Center’s Stem Cell Transplant Program offers patients participation in clinical trials and investigations. These are fundamental to our program. Our physician-scientists are pioneers in making leading-edge discoveries about the treatment of blood cancers so patients can benefit from the improved outcomes. Several of the diseases treatable with a stem cell transplant lack a standard of care, due to toxicity or lack of effectiveness of older therapies. Therefore, our approach includes the consideration of clinical trial participation for most of our transplant candidates.

The Goals of Our Clinical Trials

Well-designed clinical trials are the centerpiece of our approach. They represent the latest innovations in cancer management and treatment. The main goals of our studies are:

• Decrease the rate and severity of transplant-associated side effects
• To extend stem cell transplants to most patients in need of this form of treatment
• Increase the cure rates by using new ways of delivering chemotherapy and radiation therapy in the transplant process

Progress with Blood and Marrow Stem Cells

Some of the clinical trials currently in development include:

• Cord blood ex-vivo expansion with mesenchymal stromal cells. This study aims at increasing the number of cells contained in umbilical cord blood prior to transplantation, by cultivating the cells in the laboratory. Cell dose is a frequent limitation for adults eligible for this type of transplant, a problem that leads to longer time in the hospital and other side effects.
• Use of targeted radiation to the bone marrow in order to decrease toxicity to other organs.
• Post transplant interventions to prevent leukemia relapse. We aim to prevent recurrence of acute myelogenous leukemia and myelodysplastic syndrome after a donor cell transplant.

We also offer studies for leukemias, myelodysplastic syndrome, lymphomas, multiple myeloma and other diseases through the Blood and Marrow Transplant Clinical Trial Networks (BMT CTN), including:

• Assessments of a full ablation transplant versus reduced conditioning for patients with acute leukemia in remission. In the past we have used heavy doses of chemotherapy and/or radiation therapy that was potentially very toxic. Today we are seeking a less invasive therapy that results in a positive outcome.
• Investigations of reduced intensity therapy with the same goal to replace the immune system with a healthy donor’s. This trial offers patients a less intensive and less toxic regimen, using special kinds of chemo that are more focused on eliminating the patient’s immune system rather than getting rid of the entire blood system. This clinical investigation seeks to see whether this different strategy may be better even for older patient in their mid-seventies.
• Stem cell transplant for multiple myeloma. Through the Clinical Trials Network, we are assessing different strategies using autologous stem cells as part of the treatment and comparing methods of collecting cells using various medications.

In addition to these investigator-initiated trials, we also participate in multiple large national cooperative groups and international clinical trials enrolling patients with various types of cancers.

Individualized Assessment and Recommendations

We consider clinical trials to be excellent treatment for patients, and we encourage participation. A clinical trial nurse who is intimately familiar with the study reviews the trial with patients, including getting informed consent. We urge patients to review the information with their families and come back once they have made a decision.

In addition, a major drive in medicine is individualized therapy. Our goal is to make therapy match the patient’s particular needs, avoiding over treatment and under dosing. This is particularly significant to treatment with chemotherapy.