Graft-vs-Host DiseasePhase 1Homeo-GHNCT01318330
Safety Study of Homeo-GH (Bone Marrow Derived Clonal Mesenchymal Stem Cell) to Treat Acute/Chronic Graft Versus Host Disease (GVHD)
A Phase 1 study testing Homeo-GH in people with Graft-vs-Host Disease, run by HomeoTherapy Co., Ltd at 4 sites in South Korea.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft-vs-Host Disease
- What is being tested?
- Homeo-GH
- How many people
- 10 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Nov 2010to Jun 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Inha University Hospital
Incheon, 400-712
Seoul National University Hospital
Seoul, 110-744
Seoul St. Mary's Hospital
Seoul, 137-701
Asan Medical Center
Seoul, 138-736
About this study
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
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
Read the 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
- Conditions
- Graft-vs-Host Disease
- Being tested
- Homeo-GH
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homeo-GHDrug
Bone Marraw derived Clonal Mesenchymal Stem Cell (cMSC)
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within the first 5 week
Secondary outcomes (1)
GVHD clinical response
Clinical response was evaluated base on GVHD grding system
- CR (Complete Response)
- PR (Partial Response)
- SD (Stable Disease)
- PD (Progressive Disease)
Measured: Within the first 5 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startNov 2010
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft-vs-Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HomeoTherapy Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- SunUk Song, Ph.D., Study director, Inha Univ. College of MedicineCharles, JH Kim, Ph.D., Study director, HomeoTherapy Co., LtdHyun Gyu Lee, M.D.,Ph.D., Principal investigator, Inha Univerisity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318330
- Sponsor's protocol ID
- Homeo-GH
- Acronym
- Homeo-GH
- Status last verified
- Mar 2011
- First submitted
- 14 Mar 2011
- Last updated
- 19 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01318330
- Acronym / sponsor ID
- Homeo-GH / Homeo-GH
- Conditions
- Graft-vs-Host Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- HomeoTherapy Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 18 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homeo-GHBone Marraw derived Clonal Mesenchymal Stem Cell (cMSC) | Drug | – |
Primary outcome
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
1 secondary outcome
GVHD clinical response
Time frame: Within the first 5 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SunUk Song, Ph.D. study director
Inha Univ. College of Medicine
Charles, JH Kim, Ph.D. study director
HomeoTherapy Co., Ltd
Hyun Gyu Lee, M.D.,Ph.D. principal investigator
Inha Univerisity Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Homeo-GH in people with Graft-vs-Host Disease, run by HomeoTherapy Co., Ltd at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate number of paticipants with adverse events (time frame: Within the first 5 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2012.