Back to resultsAllogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer (MSC)
Primary Purpose
Prostate Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Allogeneic Human Mesenchymal Stem Cells
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
MSC Donors
Inclusion Criteria:(MSC donor cohort):
- 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
Exclusion Criteria:(MSC donor cohort):
- 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
Inclusion Criteria (Treatment cohort):
- 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
Exclusion Criteria (Treatment cohort):
- 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.
- 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.
- Any active autoimmune disease requiring treatment (e.g. steroid, disease-modifying antirheumatic drugs, biologic agents, etc.).
- Prior history of penicillin or streptomycin allergy.
- No prior history of deep venous thrombosis or pulmonary embolism within 5 years prior to enrollment in the study.
- Abnormal liver function (bilirubin, AST, ALT ≥ 3 x upper limit of normal)
- Abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal)
- 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.
- History of symptomatic pulmonary dysfunction.
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Allogeneic Human Mesenchymal Stem Cells
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Feasibility of infusing MSCs into men with localized prostate cancer who plan to undergo a prostatectomy.
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
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.
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.
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
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
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
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
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
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
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
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
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.
Full Information
NCT ID
NCT01983709
First Posted
October 28, 2013
Last Updated
July 12, 2018
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1. Study Identification
Unique Protocol Identification Number
NCT01983709
Brief Title
Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer
Acronym
MSC
Official Title
A Phase 1 Study of Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Study was Terminated by PI due to low accrual
Study Start Date
October 2013 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Allogeneic Human Mesenchymal Stem Cells
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Allogeneic Human Mesenchymal Stem Cells
Intervention 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 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.
Primary Outcome Measure Information:
Title
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
Description
Allogeneic MSCs will be quantified through tissue BEAMing and the percent of MSCs per total cell number will be calculated.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Feasibility of infusing MSCs into men with localized prostate cancer who plan to undergo a prostatectomy.
Description
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.
Time Frame
Up to 3 years
Title
Determine the proportion of MSC to recipient DNA in the peripheral blood
Description
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.
Time Frame
Up to 3 years
Title
Determine the proportion of MSC to recipient DNA within the seminal vesicle.
Description
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.
Time Frame
Up to 3 years
Title
Changes in the Sexual Health Inventory for Men (SHIM) survey post-prostatectomy.
Description
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.
Time Frame
Up to 3 years
Title
Change in urinary function as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy
Description
Change in total urinary function score (possible score range from 5-51) on the EPIC survey.
Time Frame
Baseline to Up to 3 years
Title
Change in bowel habits as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy
Description
Change in total bowel habits score (possible score range from 8-62) on the EPIC survey.
Time Frame
Baseline to Up to 3 years
Title
Change in sexual function as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy
Description
Change in total sexual function score (possible score range from 10-61) on the EPIC survey.
Time Frame
Baseline to Up to 3 years
Title
Change in hormonal function as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy
Description
Change in total hormonal function score (possible score range from 5-49) on the EPIC survey.
Time Frame
Baseline to Up to 3 years
Title
Change in overall satisfaction as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy
Description
Change in overall satisfaction score (possible score range from 1-5) on the EPIC survey with a higher score reflecting higher overall satisfaction.
Time Frame
Baseline to Up to 3 years
Title
Safety as assessed by number of participants experiencing adverse events
Description
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.
Time Frame
Up to 3 years
Title
Safety as assessed by number of participants experiencing serious adverse events
Description
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.
Time Frame
Up to 3 years
Title
Safety as assessed by number of participants experiencing treatment-related adverse events
Description
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.
Time Frame
Up to 3 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
MSC Donors
Inclusion Criteria:(MSC donor cohort):
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
Exclusion Criteria:(MSC donor cohort):
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
Inclusion Criteria (Treatment cohort):
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
Exclusion Criteria (Treatment cohort):
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.
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.
Any active autoimmune disease requiring treatment (e.g. steroid, disease-modifying antirheumatic drugs, biologic agents, etc.).
Prior history of penicillin or streptomycin allergy.
No prior history of deep venous thrombosis or pulmonary embolism within 5 years prior to enrollment in the study.
Abnormal liver function (bilirubin, AST, ALT ≥ 3 x upper limit of normal)
Abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal)
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.
History of symptomatic pulmonary dysfunction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Denmeade, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25974235
Citation
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.
Results Reference
derived
Learn more about this trial
Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer
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