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

NCT01318330 | Completed Phase 1

• 1 other identifier: Homeo-GH
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

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

Conditions

Graft-vs-Host Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• GVHD clinical response

  Within the first 5 week

Interventions

Homeo-GH DRUG

Bone Marraw derived Clonal Mesenchymal Stem Cell (cMSC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HomeoTherapy Co., Ltd: lead

Study Sites (4)

Inha University Hospital

Incheon, 400-712, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• SunUk Song, Ph.D.

  Inha Univ. College of Medicine

  STUDY DIRECTOR

• Charles, JH Kim, Ph.D.

  HomeoTherapy Co., Ltd

  STUDY DIRECTOR

• Hyun Gyu Lee, M.D.,Ph.D.

  Inha Univerisity Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 14, 2011
• First Posted: March 18, 2011
• Study Start: November 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: July 19, 2012

Record last verified: 2011-03

Locations

KR (4)