NCT01983709

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

A Phase 1 Study of Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Male
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	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 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.

Timeline

• Start date: 2013-10-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2013-11-14
• Last updated: 2018-07-16

Locations

1 site across 1 country: United States