NCT01318330: Homeo-GH

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

Completed Phase 1 Last updated 18 July 2012

What this trial tests

Phase 1 trial testing Homeo-GH in Graft-vs-Host Disease in 10 participants. Completed in 1 June 2012.

Timeline

1 November 2010

Primary endpoint
1 December 2011

1 June 2012

Quick facts

Lead sponsor	HomeoTherapy Co., Ltd
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Enrollment	10
Start date	1 November 2010
Primary completion	1 December 2011
Estimated completion	1 June 2012
Sites	4 locations across South Korea

Drugs / interventions tested

• Homeo-GH — full drug profile →

Conditions studied

• Graft-vs-Host Disease — all drugs for Graft-vs-Host Disease →

Sponsor

HomeoTherapy Co., Ltd — full company profile →

Who can join

18 and older, any sex, with Graft-vs-Host Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mesenchymal stem/stromal cells as a valuable source for the treatment of immune-mediated disorders.
   Markov A, Thangavelu L, Aravindhan S, Zekiy AO, et al · · 2021 · cited 174× · PMID 33736695 · DOI 10.1186/s13287-021-02265-1
2. Immunomodulatory Mechanisms of Mesenchymal Stem Cells and Their Potential Clinical Applications.
   Huang Y, Wu Q, Tam PKH. · · 2022 · cited 143× · PMID 36077421 · DOI 10.3390/ijms231710023
3. Potential clinical applications of adult human mesenchymal stem cell (Prochymal®) therapy.
   Patel AN, Genovese J. · · 2011 · cited 35× · PMID 24198531 · DOI 10.2147/sccaa.s11991
4. Mesenchymal stem cell-based therapy for autoimmune-related fibrotic skin diseases-systemic sclerosis and sclerodermatous graft-versus-host disease.
   Yang H, Cheong S, He Y, Lu F. · · 2023 · cited 16× · PMID 38111001 · DOI 10.1186/s13287-023-03543-w
5. The roles and clinical applications of mesenchymal stem cells and their exosomes in hematologic diseases.
   Deng M, Zhang X, Zhang Y. · · 2025 · PMID 41444972 · DOI 10.1186/s13287-025-04880-8