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

Graft-vs-Host Disease Clinical Trial

— Homeo-GH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01318330
• Other study ID #: Homeo-GH
• Status: Completed
• Phase: Phase 1
• First received: March 14, 2011
• Last updated: July 18, 2012
• Start date: November 2010
• Est. completion date: June 2012

Study information

• Verified date: March 2011
• Source: HomeoTherapy Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-vs-Host Disease

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	In Cheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
HomeoTherapy Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No