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

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

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

Study Overview

• Status: Completed
• Conditions: Graft-vs-Host Disease
• Intervention / Treatment: Drug: Homeo-GH

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

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • In Cheon, Korea, Republic of, 400-712
    • Inha University Hospital
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 137-701
    • Seoul St. Mary'S Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate number of paticipants with adverse events	Aderse Events were record relationship with Investigational Product; Not related; Unlikely; Possible; Probable; High probable The severity of adverse events were graded refer to CTCAE (Common Terminology Criteria for Adverse Events) Ver.4.0	Within the first 5 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GVHD clinical response	Clinical response was evaluated base on GVHD grding system; CR (Complete Response); PR (Partial Response); SD (Stable Disease); PD (Progressive Disease)	Within the first 5 week

Collaborators and Investigators

• Sponsor: HomeoTherapy Co., Ltd
• Investigators: Study Director: SunUk Song, Ph.D., Inha Univ. College of Medicine; Study Director: Charles, JH Kim, Ph.D., HomeoTherapy Co., Ltd; Principal Investigator: Hyun Gyu Lee, M.D.,Ph.D., Inha Univerisity Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: March 14, 2011
• First Submitted That Met QC Criteria: March 17, 2011
• First Posted (ESTIMATE): March 18, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 19, 2012
• Last Update Submitted That Met QC Criteria: July 18, 2012
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: Homeo-GH