Clinical trial NCT01983709: Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer
Official title: A Phase 1 Study of Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Up to 3 years
Secondary outcomes:
measure: Feasibility of infusing MSCs into men with localized prostate cancer who plan to undergo a prostatectomy.
timeFrame: Up to 3 years
measure: Determine the proportion of MSC to recipient DNA in the peripheral blood
timeFrame: Up to 3 years
measure: Determine the proportion of MSC to recipient DNA within the seminal vesicle.
timeFrame: Up to 3 years
measure: Changes in the Sexual Health Inventory for Men (SHIM) survey post-prostatectomy.
timeFrame: Up to 3 years
measure: Change in urinary function as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy
timeFrame: Baseline to Up to 3 years
measure: Change in bowel habits as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy
timeFrame: Baseline to Up to 3 years
measure: Change in sexual function as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy
timeFrame: Baseline to Up to 3 years
measure: Change in hormonal function as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy
timeFrame: Baseline to Up to 3 years
measure: Change in overall satisfaction as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy
timeFrame: Baseline to Up to 3 years
measure: Safety as assessed by number of participants experiencing adverse events
timeFrame: Up to 3 years
measure: Safety as assessed by number of participants experiencing serious adverse events
timeFrame: Up to 3 years
measure: Safety as assessed by number of participants experiencing treatment-related adverse events
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Samuel Denmeade, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.