Clinical trial 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Graft-vs-Host Disease
Lead sponsor: HomeoTherapy Co., Ltd
Sponsor class: INDUSTRY
First posted: 2011-03-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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

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 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

Primary outcomes:
measure: To evaluate number of paticipants with adverse events
timeFrame: Within the first 5 week
Secondary outcomes:
measure: GVHD clinical response
timeFrame: Within the first 5 week
Other outcomes:
Locations:
city: In Cheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Inha Univ. College of Medicine
name: SunUk Song, Ph.D.
role: STUDY_DIRECTOR
affiliation: HomeoTherapy Co., Ltd
name: Charles, JH Kim, Ph.D.
role: STUDY_DIRECTOR
affiliation: Inha Univerisity Hospital
name: Hyun Gyu Lee, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: