Chronic Graft-Versus-Host DiseasePhase 3MSC-cGvHDNCT02291770
Treatment of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal Cells
A Phase 3 study testing Mesenchymal Stromal Cells in people with Chronic Graft-Versus-Host Disease, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Chronic Graft-versus-Host Disease (cGvHD) is a potentially lethal disorder. A variety of second line immunosuppressive agents have been investigated but no optimal treatment has emerged. There is therefore a need for novel treatment strategies. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Chronic Graft-Versus-Host Disease
- What is being tested?
- Mesenchymal Stromal Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Dec 2019
- Phase
- Phase 3
- 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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newly diagnosed cGvHD
- Informed consent obtained from patient and donor.
- Any patient who has undergone allogeneic stem cell transplantation with c GvHD.
- Have not received additional agent for cGVHD within 3 months.
- Expected life is more than 90 days.
- Adequate pulmonary function with no evidence of chronic obstructive or severe restrictive pulmonary disease.
- Adequate cardiac function with no evidence of uncontrolled high blood pressure,congestive heart failure, angina pectoris, acute myocardial infarction within 6 months prior to the process.
Who cannot join
- Invasive fungal disease.
- Active cytomegalovirus (CMV)/Epstein-Barr virus(EBV)/varicella disease).
- Patient is with a history of hypersensitivity to bovine products.
- Relapsed malignancy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xin Du
Guangzhou, Guangdong, 510080
Xin Du, Prof., miaydu@hotmail.com
Peilong Lai, Dr., +86 02083827812-62121, lai_peilong@163.com
About this study
Official title: Treatment of of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal Cells. A Phase III Randomized Open Label Multi-center Study in Southern China.
Chronic Graft-versus-Host Disease (cGvHD) is a potentially lethal disorder. A variety of second line immunosuppressive agents have been investigated but no optimal treatment has emerged. There is therefore a need for novel treatment strategies. Mesenchymal stromal cells (MSC) exhibit immunomodulatory properties and a recent pilot study suggests a response rate of 70% in steroid- refractory patients. In the present randomized study the efficacy and safety of MSC treatment will be further studied in patients with cGvHD.
- Conditions
- Chronic Graft-Versus-Host Disease
- Being tested
- Mesenchymal Stromal Cells
- Keywords
- Chronic Graft-Versus-Host Disease, Mesenchymal Stromal Cells
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stromal CellsBiological
Also called MSC
Mesenchymal stem cell(MSC). Patients with newly diagnosed cGvHD: prednisone 1mg/kg + cyclosporine or tacrolimus and MSC 2×1,000,000 MSC/kg, IV twice a week for the first two weeks and weekly for the following two weeks(6 doses totally).
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cells (MSC) | Active comparator | Patients with newly diagnosed cGvHD receive primary treatment plus MSC:
1. MSC+prednisone+cyclosporine;
2. MSC+prednisone+tacrolimus;
3. MSC+prednisone+mycophenolate mofetil. Receives: Biological: Mesenchymal Stromal Cells |
| Placebo | Placebo comparator | Patients with newly diagnosed cGvHD receive primary treatment: 1. Placebo+prednisone+cyclosporine; 2. Placebo+prednisone+tacrolimus; 3. Placebo+prednisone+mycophenolate mofetil. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients responding to treatment of cGvHD with MSC
Measured: 90 days
Secondary outcomes (5)
Overall survival
Measured: 2 year
Progression-free survival
Measured: 2 year
Time without systemic immunosuppression
Measured: 2 year
Cumulative incidents of non-relapse mortality
Measured: 2 year
Adverse events
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2015 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Graft-Versus-Host DiseaseStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University, Nanfang Hospital, Southern Medical University, Guangzhou General Hospital of Guangzhou Military Command, Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou First People's Hospital, Academy Military Medical Science, China
- Responsible party
- Sponsor
- Investigators
- Xin Du, Prof., Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291770
- Sponsor's protocol ID
- No.GRDEC 2014210H
- Acronym
- MSC-cGvHD
- Status last verified
- Nov 2014
- First submitted
- 5 Nov 2014
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weng J, He C, Lai P, Luo C, Guo R, Wu S, Geng S, Xiangpeng A, Liu X, Du X. Mesenchymal stromal cells treatment attenuates dry eye in patients with chronic graft-versus-host disease. Mol Ther. 2012 Dec;20(12):2347-54. doi: 10.1038/mt.2012.208. Epub 2012 Oct 16.
PubMed 23070118Weng JY, Du X, Geng SX, Peng YW, Wang Z, Lu ZS, Wu SJ, Luo CW, Guo R, Ling W, Deng CX, Liao PJ, Xiang AP. Mesenchymal stem cell as salvage treatment for refractory chronic GVHD. Bone Marrow Transplant. 2010 Dec;45(12):1732-40. doi: 10.1038/bmt.2010.195. Epub 2010 Sep 6.
PubMed 20818445
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal Cells. A Phase III Randomized Open Label Multi-center Study in Southern China.
- ClinicalTrials.gov ID
- NCT02291770
- Acronym / sponsor ID
- MSC-cGvHD / No.GRDEC 2014210H
- Conditions
- Chronic Graft-Versus-Host Disease
- Keywords
- Chronic Graft-Versus-Host Disease, Mesenchymal Stromal Cells
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, Nanfang Hospital, Southern Medical University, Guangzhou General Hospital of Guangzhou Military Command, Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou First People's Hospital, Academy Military Medical Science, China
- Study start
- Oct 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 14 Nov 2014 (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.
Chronic Graft-versus-Host Disease (cGvHD) is a potentially lethal disorder. A variety of second line immunosuppressive agents have been investigated but no optimal treatment has emerged. There is therefore a need for novel treatment strategies. Mesenchymal stromal cells (MSC) exhibit immunomodulatory properties and a recent pilot study suggests a response rate of 70% in steroid- refractory patients. In the present randomized study the efficacy and safety of MSC treatment will be further studied in patients with cGvHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cells (MSC) | Active comparator | Biological: Mesenchymal Stromal CellsPatients with newly diagnosed cGvHD receive primary treatment plus MSC: 1. MSC+prednisone+cyclosporine; 2. MSC+prednisone+tacrolimus; 3. MSC+prednisone+mycophenolate mofetil. |
| Placebo | Placebo comparator | –Patients with newly diagnosed cGvHD receive primary treatment: 1. Placebo+prednisone+cyclosporine; 2. Placebo+prednisone+tacrolimus; 3. Placebo+prednisone+mycophenolate mofetil. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Newly diagnosed cGvHD
- Informed consent obtained from patient and donor.
- Any patient who has undergone allogeneic stem cell transplantation with c GvHD.
- Have not received additional agent for cGVHD within 3 months.
- Expected life is more than 90 days.
Key exclusion criteria (4 listed)
- Invasive fungal disease.
- Active cytomegalovirus (CMV)/Epstein-Barr virus(EBV)/varicella disease).
- Patient is with a history of hypersensitivity to bovine products.
- Relapsed malignancy.
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 |
|---|---|---|
| Mesenchymal Stromal CellsAlso: MSCMesenchymal stem cell(MSC). Patients with newly diagnosed cGvHD: prednisone 1mg/kg + cyclosporine or tacrolimus and MSC 2×1,000,000 MSC/kg, IV twice a week for the first two weeks and weekly for the following two weeks(6 doses totally). | Biological | Mesenchymal stem cells (MSC) |
Primary outcome
Proportion of patients responding to treatment of cGvHD with MSC
Time frame: 90 days
5 secondary outcomes
Overall survival
Time frame: 2 year
Progression-free survival
Time frame: 2 year
Time without systemic immunosuppression
Time frame: 2 year
Cumulative incidents of non-relapse mortality
Time frame: 2 year
Adverse events
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
- Background: PubMed 23070118Weng J, He C, Lai P, Luo C, Guo R, Wu S, Geng S, Xiangpeng A, Liu X, Du X. Mesenchymal stromal cells treatment attenuates dry eye in patients with chronic graft-versus-host disease. Mol Ther. 2012 Dec;20(12):2347-54. doi: 10.1038/mt.2012.208. Epub 2012 Oct 16.
- Background: PubMed 20818445Weng JY, Du X, Geng SX, Peng YW, Wang Z, Lu ZS, Wu SJ, Luo CW, Guo R, Ling W, Deng CX, Liao PJ, Xiang AP. Mesenchymal stem cell as salvage treatment for refractory chronic GVHD. Bone Marrow Transplant. 2010 Dec;45(12):1732-40. doi: 10.1038/bmt.2010.195. Epub 2010 Sep 6.
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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.
Xin Du, Prof. principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mesenchymal Stromal Cells in people with Chronic Graft-Versus-Host Disease, run by Guangdong Provincial People's Hospital at 1 site in China.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Du, Prof. (+86 02083827812-62122, miyadu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients responding to treatment of cGvHD with MSC (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02291770, which also lists 2 linked publications.
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 14 Nov 2014.