A Phase I Study of Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer
Johns Hopkins Kimmel Cancer Center in Baltimore
This research is being done to determine whether mesenchymal stem cells (MSCs) will migrate to the sites of prostate cancer following an intravenous (IV) infusion of the MSCs in men prior to receiving a prostatectomy as treatment for newly diagnosed prostate cancer. MSCs are considered an investigational. The word "investigational" means MSCs are not approved by the U. S. Food and Drug Administration (FDA) standard treatment for men with prostate cancer or any other diseases and are still being tested in research studies. However, the FDA is allowing the use of MSCs in this study.
FOR PROSTATE CANCER PATIENTS: Inclusion Criteria (Treatment cohort) 1. Age greater than / equal to 18 years 2. Eastern cooperative group (ECOG) performance status less than / equal to 2 3. Documented histologically confirmed adenocarcinoma of the prostate 4. Gleason score on diagnostic biopsy specimens of greater than / equal to 6 5. greater than / equal to 3 positive cores within diagnostic biopsy specimens 6. At least one prostate core must contain greater than / equal to 30% prostate cancer 7. Scheduled to undergo a prostatectomy at Johns Hopkins 8. Has not received systemic therapy for prostate cancer (i.e. LHRH agonist/antagonist therapy) 9. Sexual Health Inventory in Men (SHIM) score greater than / equal to 17 Exclusion Criteria (Treatment cohort): 1. Prior radiation therapy to the prostate. 2. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study. 3. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule. 4. Inability to provide informed consent. 5. Any active autoimmune disease requiring treatment (e.g. steroid, disease- modifying antirheumatic drugs, biologic agents, etc.). 6. Prior history of penicillin or streptomycin allergy. 7. No prior history of deep venous thrombosis or pulmonary embolism within 5 years prior to enrollment in the study 8. Abnormal liver function (bilirubin, AST, ALT greater than / equal to 3 x upper limit of normal) 9. Abnormal kidney function (serum creatinine greater than / equal to 2 x upper limit of normal) 10. Abnormal cardiac function as manifested by NYHA (New York Heart Association) class III or IV heart failure or history of a prior myocardial infarction (MI) within the last five years prior to enrollment in the study. 11. History of symptomatic pulmonary dysfunction. FOR STEM CELL DONORS: Inclusion Criteria (MSC donors): 1. Age greater than / equal to 18 years, less than / equal to 30 years 2. Male sex 3. Donor must meet the selection and eligibility criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT) and FDA 21 CFR Part 1271 Exclusion Criteria (MSC donor cohort): 1. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study. 2. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
FOR PROSTATE CANCER PATIENTS: --Prostate cancer patients will be asked to do the following things: (1) You will receive 4 bags of mesenchymal stem cells through an IV given once 4 to 8 days prior to having your prostate removed. (2) You will have 3 clinic visits as part of this trial, not including your otherwise planned surgery. These visits will occur over a time span of less than 60 days. You will have about 2-3 tablespoons of blood drawn at each clinic visit and also at the time of your surgery. FOR STEM CELL DONORS: --Stem cell donors will be asked to do the following things: (1) Have 3 clinic visits as part of this trial over 14 days or so. This is the time that it will take to screen you for eligibility, collect your bone marrow, and follow up with you to make sure you tolerated the bone marrow collection. (2) Blood will be tested for HIV and other infectious disease markers. If the HIV test is positive, it does not always mean that you are infected with the HIV virus. It means you will need further testing and you will receive counseling. The law requires us to report positive tests to the health department. You will also have a test for hepatitis B and C. If the results of this test show that you have hepatitis B or C or both, the law requires us to report this to the health department. (3) Blood samples will also be taken in preparation for studies that will allow us to detect your MSCs near sites of prostate cancer in the men who are treated with your MSCs. The intent is that you donate your bone marrow and blood to Johns Hopkins Hospital for clinical research.
05/28/2016 05:03 AM