Clinical Trials

The Center for Stem Cell and Regenerative Medicine has treated over 250 patients with adult stem cells and over 60 patients in cell therapy related clinical trials. Since its inception in 2003, 51 clinical trials have been held or are currently enrolling patients.

The following is a list of current, enrolling clinical trials being done at the Center:

1. A Phase I Study to Assess the Feasibility, Safety, and Tolerability of Autologous Mesenchymal Stem Cell Transplantation in Patients With Relapsing Forms of Multiple Sclerosis (Clinical Trials.Gov Identifier: NCT00813969)

1. A Phase I, Multicenter, Dose-Escalation Trial Evaluating Maximum-Tolerated Dose of Single and Repeated Administration of Allogeneic MultiStem® in Patients with Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplasia (ClinicalTrials.Gov Identifier: NCT00677859)
   
   
2. A Phase I, Multicenter, Dose-Escalation Trial Evaluating the Safety of Allogenic MultiStem® in Patients with Acute Myocardial Infarction (Clinical Trials.Gov Identifier: NCT00677222)
   
   
3. Longterm Observational Followup Study of a Multicenter, Randomized, Double Blind, Placebo-Controlled, Comparative Trial of AMD3100 (240 ug/kg) plus G-CSF (10 ug/kg) versus G-CSF (10 ug/kg) plus Placebo to Mobilize and Collect Greater than or Equal to 5 X 10 6 CD34+ Cells/Kg in Non-Hodgkin's Lymphoma Patients for Autologous Transplantation
   
   
4. Longterm Observational Followup Study of a Multicenter, Randomized, Double Blind, Placebo-Controlled, Comparative Trial of AMD3100 (240 ug/kg) plus G-CSF (10 ug/kg) versus G-CSF (10 ug/kg) plus Placebo to Mobilize and Collect Greater than or Equal to 6 X 10 6 CD34+ Cells/Kg in Multiple Myeloma Patients for Autologous Transplantation
   
   
5. Compassionate use Protocol for the Use of AMD3100 to Mobilize Peripheral Blood Stem Cells for Collection & Transplantation
   
   
6. A Phase III Randomized, Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cells with Marrow Transplantation from HLA Compatible Unrelated Donors

1. Phase III Rituxan/BEAM vs Bexxar/BEAM with Autologous Hematopoietic Stem Cell Transplantation (ASCT) for Persistent and Relapsed Chemotherapy Sensitive Diffuse Large B-Cell Non-Hodgkin's Lymphoma (ClinicalTrials.Gov Identifier: NCT00329030)
   
   
2. A Phase III Randomized, Multicenter Trial Comparing Sirolimus/Tacrolimus with Tacrolimus/Methotrexate as Graft vs Host Disease (GVHD) Prophylaxis after HLA-Matched, Related Peripheral Blood Stem Cell Transplantation (ClinicalTrials.Gov Identifier: NCT00406393)
   
   
3. Phase II Safety and Efficacy Study of the Monoclonal Antibody CT-011 in Patients with Diffuse Large B-Cell Lymphoma following Autologous Stem Cell Transplantation (ClinicalTrials.Gov Identifier: NCT00532259)
   
   
4. Donor Mesenchymal Stem Cell Infusion for Treatment of Graft versus Host Disease: A Phase I-II Trial
   
   
5. Role of DNA Repair in Human Hematopoietic Stem Cell Function
   
   
6. A Pilot Study of Multiple Umbilical Cord Blood Unit Transplantation Following Non-Myeloablative Conditioning in Patients with Hematologic Disorders (ClinicalTrials.Gov Identifier: NCT00054236)
   
   
7. A Phase II Study of Reduced Intensity Allogeneic Stem Cell Transplant for the Treatment of Myelodysplastic Syndrome (ClinicalTrials.Gov Identifier: NCT00045305)
   
   
8. Protocol for a Research Sample Repository for Allogeneic Unrelated Hematopoietic Stem Cell Transplantation
   
   
9. A Research Database for Allogeneic Unrelated Hematopoietic Stem Cell Transplantation
   
   
10. A Multi-Center, Multi-National, Historical Cohort Controlled Study to Evaluate Efficacy and Safety of Transplantation of StemEx, Umbilical Cord Blood Stem and Progenitor Cells Expanded Ex Vivo, in Subjects with Hematologic Malignancies following Myeloablative Therapy
    
    
11. Retrospective Analysis of the Association Between MGMT Promoter Methylation and Survival Following Protocol Therapy in Malignant Gliomas
    
    
12. 06-benzylguanine (BG) and Temozolomide (TMZ) Therapy of Glioblastoma Multiforme (GBM) in Patients with MGMT Positive Tumors with Infusion of Autologous P140KMGMT+ Hematopoietic Progenitors to Protect Hematopoiesis
    
    
13. Open-Label Single-Arm Pilot Study Of Deferasirox (Exjade (R)) In Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload (ClinicalTrials.gov Identifier: NCT00602446)
    

For more information on these clinical trials, please visit the following website and type in the ClinicalTrials.gov Identifier into the "NCT or Study ID" search box. http://www.clinicaltrials.gov/ct/screen/advancedsearch

If you require further assistance in obtaining clinical trial information from the Center or other institutions please contact Michael Gilkey at michael.gilkey@case.edu