A Phase 1 Study of Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01983709

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum 100 Years
  • Gender: Male

Inclusion Criteria:

  1. (MSC donor cohort):
  2. Age ≥18 years, ≤30 years
  3. Male sex
  4. Donor must meet the selection and

Eligibility Criteria:

  1. as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT) and FDA 21 CFR Part 1271 Exclusion Criteria:(MSC donor cohort):
  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. MSC Recipients Inclusion Criteria (Treatment cohort):
  5. Age ≥18 years
  6. Eastern cooperative group (ECOG) performance status ≤2
  7. Documented histologically confirmed adenocarcinoma of the prostate
  8. Gleason score on diagnostic biopsy specimens of ≥ 6
  9. ≥ 3 positive cores within diagnostic biopsy specimens
  10. At least one prostate core must contain ≥ 30% prostate cancer
  11. Scheduled to undergo a prostatectomy at Johns Hopkins
  12. Has not received systemic therapy for prostate cancer (i.e. LHRH agonist/antagonist therapy)
  13. Sexual Health Inventory in Men (SHIM) score ≥ 17

Exclusion Criteria:

  1. (MSC donor cohort):
  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. MSC Recipients Inclusion Criteria (Treatment cohort):
  5. Age ≥18 years
  6. Eastern cooperative group (ECOG) performance status ≤2
  7. Documented histologically confirmed adenocarcinoma of the prostate
  8. Gleason score on diagnostic biopsy specimens of ≥ 6
  9. ≥ 3 positive cores within diagnostic biopsy specimens
  10. At least one prostate core must contain ≥ 30% prostate cancer
  11. Scheduled to undergo a prostatectomy at Johns Hopkins
  12. Has not received systemic therapy for prostate cancer (i.e. LHRH agonist/antagonist therapy)
  13. Sexual Health Inventory in Men (SHIM) score ≥ 17 Exclusion Criteria (Treatment cohort):
  14. Prior radiation therapy to the prostate.
  15. 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.
  16. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
  17. Inability to provide informed consent.
  18. Any active autoimmune disease requiring treatment (e.g. steroid, disease-modifying antirheumatic drugs, biologic agents, etc.).
  19. Prior history of penicillin or streptomycin allergy.
  20. No prior history of deep venous thrombosis or pulmonary embolism within 5 years prior to enrollment in the study.
  21. Abnormal liver function (bilirubin, AST, ALT ≥ 3 x upper limit of normal)
  22. Abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal)
  23. 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.
  24. History of symptomatic pulmonary dysfunction.

View trial on ClinicalTrials.gov