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

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ClinicalTrials.gov Identifier: NCT01983709
Recruitment Status : Terminated (Study was Terminated by PI due to low accrual)
First Posted : November 14, 2013
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE October 28, 2013
First Posted Date  ICMJE November 14, 2013
Last Update Posted Date July 16, 2018
Actual Study Start Date  ICMJE October 2013
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
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 [ Time Frame: Up to 3 years ]
Allogeneic MSCs will be quantified through tissue BEAMing and the percent of MSCs per total cell number will be calculated.
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2013)
To quantify the 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 [ Time Frame: Up to 3 years ]
To quantify the amount of systemically infused allogeneic bone marrow derived mesenchymal stem cell (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 at Johns Hopkins. Allogeneic MSCs will be quantified through tissue BEAMing.
Change History Complete list of historical versions of study NCT01983709 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
  • Feasibility of infusing MSCs into men with localized prostate cancer who plan to undergo a prostatectomy. [ Time Frame: Up to 3 years ]
    The percentage of screened subjects that agreed to receive a pre-prostatectomy infusion of MSCs at the pre-specified time point and subsequently undergo a radical prostatectomy.
  • Determine the proportion of MSC to recipient DNA in the peripheral blood [ Time Frame: Up to 3 years ]
    Proportion of MSC to recipient DNA is calculated by number of MSCs over the number of recipient DNA ([number of MSC]/[number of recipient DNA]) in the peripheral blood.
  • Determine the proportion of MSC to recipient DNA within the seminal vesicle. [ Time Frame: Up to 3 years ]
    Proportion of MSC to recipient DNA is calculated by number of MSCs over the number of recipient DNA ([number of MSC]/[number of recipient DNA]) in the seminal vesicle.
  • Changes in the Sexual Health Inventory for Men (SHIM) survey post-prostatectomy. [ Time Frame: Up to 3 years ]
    The SHIM is a measure of sexual function with a score ranging from 1 (severe erectile dysfunction) to 25 (normal function). Participants are required to have a score of >=17 to be eligible for the study.
  • Change in urinary function as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy [ Time Frame: Baseline to Up to 3 years ]
    Change in total urinary function score (possible score range from 5-51) on the EPIC survey.
  • Change in bowel habits as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy [ Time Frame: Baseline to Up to 3 years ]
    Change in total bowel habits score (possible score range from 8-62) on the EPIC survey.
  • Change in sexual function as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy [ Time Frame: Baseline to Up to 3 years ]
    Change in total sexual function score (possible score range from 10-61) on the EPIC survey.
  • Change in hormonal function as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy [ Time Frame: Baseline to Up to 3 years ]
    Change in total hormonal function score (possible score range from 5-49) on the EPIC survey.
  • Change in overall satisfaction as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy [ Time Frame: Baseline to Up to 3 years ]
    Change in overall satisfaction score (possible score range from 1-5) on the EPIC survey with a higher score reflecting higher overall satisfaction.
  • Safety as assessed by number of participants experiencing adverse events [ Time Frame: Up to 3 years ]
    Number of participants experiencing adverse events as defined by the revised National Cancer Institute Common Toxicity Criteria (NCI CTC), version 4.0 published 14 June 2010.
  • Safety as assessed by number of participants experiencing serious adverse events [ Time Frame: Up to 3 years ]
    Number of participants experiencing serious adverse events as defined by the revised National Cancer Institute Common Toxicity Criteria (NCI CTC), version 4.0 published 14 June 2010.
  • Safety as assessed by number of participants experiencing treatment-related adverse events [ Time Frame: Up to 3 years ]
    Number of participants experiencing treatment-related adverse events as defined by the revised National Cancer Institute Common Toxicity Criteria (NCI CTC), version 4.0 published 14 June 2010.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2013)
  • Feasibility of infusing MSCs into men with localized prostate cancer who plan to undergo a prostatectomy. [ Time Frame: Up to 3 years ]
    The proportion of enrolled subjects that receive a pre-prostatectomy infusion of MSCs at the pre-specified time point and subsequently undergo a radical prostatectomy.
  • Determine the proportion of MSC to recipient DNA in the peripheral blood at serial time points. [ Time Frame: Up to 3 years ]
  • Determine the proportion of MSC to recipient DNA within the seminal vesicle. [ Time Frame: Up to 3 years ]
  • Changes in the Sexual Health Inventory for Men (SHIM) and Expanded Prostate Cancer Index Composite (EPIC) surveys post-prostatectomy. [ Time Frame: Up to 3 years ]
  • Safety [ Time Frame: Up to 3 years ]
    Evaluated by the incidence, severity, duration, causality, seriousness, and type(s) of adverse events as assessed by the revised National Cancer Institute Common Toxicity Criteria (NCI CTC), version 4.0 published 14 June 2010.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer
Official Title  ICMJE A Phase 1 Study of Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Biological: 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.

Study Arms  ICMJE Experimental: 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.

Intervention: Biological: Allogeneic Human Mesenchymal Stem Cells
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 26, 2017)
7
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2013)
30
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01983709
Other Study ID Numbers  ICMJE J1348
NA_00083720 ( Other Identifier: JHMIRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Samuel Denmeade, MD Johns Hopkins University
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP