Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer

MSC Donors

Inclusion Criteria:(MSC donor cohort):

1. Age ≥18 years, ≤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.

3. Inability to provide informed consent.

MSC Recipients

Inclusion Criteria (Treatment cohort):

1. Age ≥18 years

2. Eastern cooperative group (ECOG) performance status ≤2

3. Documented histologically confirmed adenocarcinoma of the prostate

4. Gleason score on diagnostic biopsy specimens of ≥ 6

5. ≥ 3 positive cores within diagnostic biopsy specimens

6. At least one prostate core must contain ≥ 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 ≥ 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 ≥ 3 x upper limit of normal)

9. Abnormal kidney function (serum creatinine ≥ 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.