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

NCT01983709 | Terminated Phase 1 DMC

• 2 other identifiers: J1348NA_00083720
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Amount of systemically infused (MSC) DNA relative to recipient DNA at sites of prostate cancer in men with localized adenocarcinoma of the prostate that are scheduled to undergo a prostatectomy

  Allogeneic MSCs will be quantified through tissue BEAMing and the percent of MSCs per total cell number will be calculated.

  Up to 3 years

Secondary Outcomes (12)

• Feasibility of infusing MSCs into men with localized prostate cancer who plan to undergo a prostatectomy.

  Up to 3 years

• Determine the proportion of MSC to recipient DNA in the peripheral blood

  Up to 3 years

• Determine the proportion of MSC to recipient DNA within the seminal vesicle.

  Up to 3 years

• Changes in the Sexual Health Inventory for Men (SHIM) survey post-prostatectomy.

  Up to 3 years

• Change in urinary function as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy

  Baseline to Up to 3 years

Study Arms (1)

Allogeneic Human Mesenchymal Stem Cells

EXPERIMENTAL

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.

Biological: Allogeneic Human Mesenchymal Stem Cells

Interventions

Allogeneic Human Mesenchymal Stem Cells 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.

Allogeneic Human Mesenchymal Stem Cells

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years, ≤30 years
• Male sex
• 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

You may not qualify if:

• 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.
• Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
• Inability to provide informed consent.
• MSC Recipients
• Age ≥18 years
• Eastern cooperative group (ECOG) performance status ≤2
• Documented histologically confirmed adenocarcinoma of the prostate
• Gleason score on diagnostic biopsy specimens of ≥ 6
• ≥ 3 positive cores within diagnostic biopsy specimens
• At least one prostate core must contain ≥ 30% prostate cancer
• Scheduled to undergo a prostatectomy at Johns Hopkins
• Has not received systemic therapy for prostate cancer (i.e. LHRH agonist/antagonist therapy)
• Sexual Health Inventory in Men (SHIM) score ≥ 17
• Prior radiation therapy to the prostate.
• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• 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.

  PMID: 25974235 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Samuel Denmeade, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 14, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 16, 2018

Record last verified: 2018-07

Locations

US (1)