A Phase 1 Study of Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •(MSC donor cohort):
- •Age ≥18 years, ≤30 years
- •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
排除标准
- •(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.
研究组 & 干预措施
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.
干预措施: Allogeneic Human Mesenchymal Stem Cells (Biological)
结局指标
主要结局
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
时间窗: Up to 3 years
Allogeneic MSCs will be quantified through tissue BEAMing and the percent of MSCs per total cell number will be calculated.
次要结局
- Determine the proportion of MSC to recipient DNA within the seminal vesicle.(Up to 3 years)
- Change in bowel habits as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy(Baseline to Up to 3 years)
- Change in hormonal function as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy(Baseline to Up to 3 years)
- Change in overall satisfaction as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy(Baseline to Up to 3 years)
- Safety as assessed by number of participants experiencing treatment-related adverse events(Up to 3 years)
- Feasibility of infusing MSCs into men with localized prostate cancer who plan to undergo a prostatectomy.(Up to 3 years)
- Changes in the Sexual Health Inventory for Men (SHIM) survey post-prostatectomy.(Up to 3 years)
- Safety as assessed by number of participants experiencing serious adverse events(Up to 3 years)
- Determine the proportion of MSC to recipient DNA in the peripheral blood(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)
- Safety as assessed by number of participants experiencing adverse events(Up to 3 years)
- Change in sexual function as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy(Baseline to Up to 3 years)