Safety Study of Homeo-GH (Bone Marrow Derived Clonal Mesenchymal Stem Cell) to Treat Acute/Chronic Graft Versus Host Disease (GVHD)

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Official Title: Five-Week, Multi-center, Phase I Clinical Trial to Evaluate Safety of Homeo-GH after Intra Venus Administration for the Treatment of Graft versus Host Disease Patients

Sponsor: HomeoTherapy Co.,Ltd

Study Design: Single Group, Open Label, 5 Week, Safety Study

This study is designed to evaluate the safety of ex-vivo cultured adult human clonal mesenchymal stem cells (cMSC) derived from human bone marrow in subjects experiencing acute or chronic graft-versus-host disease (GVHD).

Study Type: Interventional

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HomeoTherapy Co., Ltd

Criteria

Inclusion Criteria:

• Informed consent obtained from patient

• Patients with ages greater than 18 years

• Neutrophill count > 1,000 cells/mm3

• Adequated cardiac function with no evidence of cardiac disease

• Patients who had complete remission after bone marrow transplantation

• Patients who can sign an informed consent form by him- or her-self or legal representative

Exclusion Criteria:

• Patients with unstable transplant after bone marrow transplantation

• Patients with unstable vital sign

• Patients with positive penicillin skin test

• Patients who had transplantation to treat solid tumor

• Patients with bacterial, viral or fungal infection not being controlled by the adequate treatment (more than moderate infection)

• Patients who, in the investigator's point of view, are not in proper state for the treatment