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

Johns Hopkins Medicine

Status and phase: Terminated; Phase 1

Conditions: Prostate Cancer

Treatments: Biological: Allogeneic Human Mesenchymal Stem Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01983709

NA_00083720 (Other Identifier)

J1348

Details and patient eligibility

About

The objective of this study is to determine if systemically infused allogeneic bone marrow derived mesenchymal stem cells (MSC) home to sites of prostate cancer in men with localized adenocarcinoma of the prostate that are planning to undergo a prostatectomy. Investigators plan to systemically infuse MSCs 4, 6 or 8 days prior to enrolled subjects' planned prostatectomies. Investigators will then quantify the relative amount of donor MSC DNA to recipient DNA present in patients' explanted prostate specimens. This will be accomplished via BEAMing digital PCR. This trial will provide the foundation for future studies aimed at engineering MSCs to deliver a toxin to sites of metastatic prostate cancer.

Enrollment: 7 patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Allogeneic Human Mesenchymal Stem Cells

Experimental group

Description:

This will be a dose escalation study. The first 3 subjects will receive a single dose of 1 x 10\^6 cells/kg or a maximum dose of 1 x 10\^8 total cells IV. The remaining subjects will receive a single dose of 2 x 10\^6 cells/kg or a maximum dose of 2 x 10\^8 total cells IV.

Treatment:

Biological: Allogeneic Human Mesenchymal Stem Cells