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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01318330
Recruitment Status : Completed
First Posted : March 18, 2011
Last Update Posted : July 19, 2012
Information provided by:
HomeoTherapy Co., Ltd

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

Condition or disease Intervention/treatment Phase
Graft-vs-Host Disease Drug: Homeo-GH Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : November 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : June 2012

Intervention Details:
  • Drug: Homeo-GH
    Bone Marraw derived Clonal Mesenchymal Stem Cell (cMSC)

Primary Outcome Measures :
  1. To evaluate number of paticipants with adverse events [ Time Frame: Within the first 5 week ]

    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

Secondary Outcome Measures :
  1. GVHD clinical response [ Time Frame: Within the first 5 week ]

    Clinical response was evaluated base on GVHD grding system

    • CR (Complete Response)
    • PR (Partial Response)
    • SD (Stable Disease)
    • PD (Progressive Disease)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01318330

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Korea, Republic of
Inha University Hospital
In Cheon, Korea, Republic of, 400-712
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137-701
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
HomeoTherapy Co., Ltd
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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
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Responsible Party: Sun U. Song/Ph.D/Professor, Inha Univ. College of Medicine Identifier: NCT01318330    
Other Study ID Numbers: Homeo-GH
First Posted: March 18, 2011    Key Record Dates
Last Update Posted: July 19, 2012
Last Verified: March 2011
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases