- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01983709
Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer (MSC)
A Phase 1 Study of Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 3 years
|
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.
|
Up to 3 years
|
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.
|
Up to 3 years
|
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.
|
Up to 3 years
|
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
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Change in total urinary function score (possible score range from 5-51) on the EPIC survey.
|
Baseline to Up to 3 years
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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
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Change in total bowel habits score (possible score range from 8-62) on the EPIC survey.
|
Baseline to Up to 3 years
|
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.
|
Baseline to Up to 3 years
|
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.
|
Baseline to Up to 3 years
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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.
|
Baseline to Up to 3 years
|
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.
|
Up to 3 years
|
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.
|
Up to 3 years
|
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.
|
Up to 3 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Samuel Denmeade, MD, Johns Hopkins University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- J1348
- NA_00083720 (Other Identifier: JHMIRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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