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

NCT ID: NCT01318330

Last Updated: 2012-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-06-30

Brief 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

Detailed Description

Allogeneic MSCs being used in current human clinical trials are nonclonal, i.e., such MSCs may have other types of cells in the final stem cell product. Some concerns exist about the heterogeneity of these nonclonal MSCs that are isolated and expanded by the conventional density-gradient centrifugation method. Recently, we developed a new protocol, called the subfractionation culturing method (SCM), to generate single-cell-derived clonal MSC (cMSC) lines from whole bone marrow aspirate without employing any centrifugation step for mononuclear cells and enzyme treatment process. This method allowed us to rapidly establish single-cell-derived human clonal MSC (hcMSC) lines from raw bone marrow aspirates and to establish a library of these hcMSC lines (Song et al., 2008).

The goal of this study is to evaluate the safety of allogeneic cMSCs established by the SCM and manufactured in GMP facility. This phase I clinical trial is a multicenter, single dose study of cMSC (1 x 10e6 cMSCs/Kg recipient's bodyweight). Clonal MSCs will be infused to acute or chronic GVHD patients via an intravenous injection. Every patients will receive the same treatment

Conditions

Graft-vs-Host Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Homeo-GH

Bone Marraw derived Clonal Mesenchymal Stem Cell (cMSC)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HomeoTherapy Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Inha Univ. College of Medicine

Principal Investigators

SunUk Song, Ph.D.

Role: STUDY_DIRECTOR

Inha Univ. College of Medicine

Charles, JH Kim, Ph.D.

Role: STUDY_DIRECTOR

HomeoTherapy Co., Ltd

Hyun Gyu Lee, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Inha Univerisity Hospital

Locations

Inha University Hospital

Incheon, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Seoul St. Mary's Hospital

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

Homeo-GH

Identifier Type: -

Identifier Source: org_study_id