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Completed

NCT Number: NCT01318330

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

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

Completed

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Key information

Conditions

Graft-vs-Host Disease Graft vs Host Disease Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Inha University Hospital, Incheon, South Korea

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Homeo-GH

Drug

Bone Marraw derived Clonal Mesenchymal Stem Cell (cMSC)

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

HomeoTherapy Co., Ltd

Industry

Registry information

Official study 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

Acronym: Homeo-GH

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Mar 18, 2011
Registry last updated
Jul 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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