drugset / Trial / NCT01983709

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

NCT01983709 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-10
Primary completion
2017-06
Completion
2017-06

Outcome

Outcome not reported

Stopped (Enrollment): “Study was Terminated by PI due to low accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Allogeneic Human Mesenchymal Stem Cells Cell therapy 1e+06 cells/kg Intravenous
Subject Allogeneic Human Mesenchymal Stem Cells Cell therapy 2e+06 cells/kg Intravenous
Subject Allogeneic Human Mesenchymal Stem Cells Cell therapy 1e+08 cells Intravenous
Subject Allogeneic Human Mesenchymal Stem Cells Cell therapy 2e+08 cells Intravenous

Indications