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

This study has been completed.
Sponsor:
Information provided by:
HomeoTherapy Co., Ltd
ClinicalTrials.gov Identifier:
NCT01318330
First received: March 14, 2011
Last updated: July 18, 2012
Last verified: March 2011
  Purpose

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 Intervention Phase
Graft-vs-Host Disease
Drug: Homeo-GH
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by HomeoTherapy Co., Ltd:

Primary Outcome Measures:
  • To evaluate number of paticipants with adverse events [ Time Frame: Within the first 5 week ] [ Designated as safety issue: Yes ]

    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:
  • GVHD clinical response [ Time Frame: Within the first 5 week ] [ Designated as safety issue: No ]

    Clinical response was evaluated base on GVHD grding system

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


Estimated Enrollment: 10
Study Start Date: November 2010
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Homeo-GH
    Bone Marraw derived Clonal Mesenchymal Stem Cell (cMSC)
    Other Name: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01318330

Locations
Korea, Republic of
Inha University Hospital
In Cheon, Korea, Republic of, 400-712
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Sun U. Song/Ph.D/Professor, Inha Univ. College of Medicine
ClinicalTrials.gov Identifier: NCT01318330     History of Changes
Other Study ID Numbers: Homeo-GH
Study First Received: March 14, 2011
Last Updated: July 18, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014