Donor Mesenchymal Stem Cell Infusion in Treating Patients With Acute or Chronic Graft-Versus-Host Disease After Undergoing a Donor Stem Cell Transplant

PHASE1CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

September 30, 2004

Primary Completion Date

June 30, 2009

Study Completion Date

November 30, 2010

Conditions
Cancer
Interventions
BIOLOGICAL

graft versus host disease prophylaxis/therapy

Within 72 hours after the initiation of medical therapy (e.g., corticosteroids, cyclosporine) for graft-vs-host disease, patients undergo donor MSC infusion over 10-15 minutes.

GENETIC

fluorescence in situ hybridization

Tissue specimens are examined by CD45 immunohistochemistry and fluorescent in situ hybridization to detect hematopoietic and nonhematopoietic cells.

OTHER

immunoenzyme technique

Tissue specimens are examined by CD45 immunohistochemistry and fluorescent in situ hybridization to detect hematopoietic and nonhematopoietic cells.

OTHER

immunohistochemistry staining method

Tissue specimens are examined by CD45 immunohistochemistry and fluorescent in situ hybridization to detect hematopoietic and nonhematopoietic cells.

OTHER

laboratory biomarker analysis

Tissue specimens are examined by CD45 immunohistochemistry and fluorescent in situ hybridization to detect hematopoietic and nonhematopoietic cells.

PROCEDURE

in vitro-treated bone marrow transplantation

Within 72 hours after the initiation of medical therapy (e.g., corticosteroids, cyclosporine) for graft-vs-host disease, patients undergo donor MSC infusion over 10-15 minutes.

PROCEDURE

management of therapy complications

Patients will be evaluated for clinical signs and symptoms of GVHD weekly for up to 28 days.

Trial Locations (8)

44024

Geauga Regional Hospital, Cleveland

44060

Lake/University Ireland Cancer Center, Cleveland

44121

University Suburban Health Center, Cleveland

44122

UHHS Chagrin Highlands Medical Center, Cleveland

44130

Southwest General Health Center, Cleveland

44145

UHHS Westlake Medical Center, Cleveland

44708

Mercy Cancer Center at Mercy Medical Center, Cleveland

44106-5065

Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Case Comprehensive Cancer Center

OTHER

NCT00361049 - Donor Mesenchymal Stem Cell Infusion in Treating Patients With Acute or Chronic Graft-Versus-Host Disease After Undergoing a Donor Stem Cell Transplant | Biotech Hunter | Biotech Hunter