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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Graft-vs-Host Disease

Intervention / Treatment
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* Drug: Homeo-GH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Homeo-GH|Bone Marraw derived Clonal Mesenchymal Stem Cell (cMSC)|

What is the study measuring?
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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 |