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

NCT ID: NCT01983709

Last Updated: 2018-07-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-06-30

Brief Summary

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Allogeneic Human Mesenchymal Stem Cells

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.

Group Type: EXPERIMENTAL

Allogeneic Human Mesenchymal Stem Cells

Intervention Type: BIOLOGICAL

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 4 days prior to undergoing a planned prostatectomy.

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 either 4 or 6 days prior to the planned prostatectomy, and if additional doses of MSCs are able to be expanded, up to 6 additional men will be enrolled with a plan to treat them 8 days prior to the prostatectomy.

Interventions

Allogeneic Human Mesenchymal Stem Cells

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 4 days prior to undergoing a planned prostatectomy.

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 either 4 or 6 days prior to the planned prostatectomy, and if additional doses of MSCs are able to be expanded, up to 6 additional men will be enrolled with a plan to treat them 8 days prior to the prostatectomy.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

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

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel Denmeade, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

Khera M, Albersen M, Mulhall JP. Mesenchymal stem cell therapy for the treatment of erectile dysfunction. J Sex Med. 2015 May;12(5):1105-6. doi: 10.1111/jsm.12871. No abstract available.

Reference Type: DERIVED

PMID: 25974235 (View on PubMed)

Other Identifiers

NA_00083720

Identifier Type: OTHER

Identifier Source: secondary_id

J1348

Identifier Type: -

Identifier Source: org_study_id