Graft-versus-host DiseasePhase 2NCT01941394
Mesenchymal Stem Cells Infusion for aGVHD Prophylaxis Transplantation
A Phase 2 study testing Mesenchymal stem cells in people with Graft-versus-host Disease and Relapse, run by National Research Center for Hematology, Russia at 1 site in Russia.
Trial summary
Infusion of Mesenchymal Stem Cell (MSC) at day of recovery after bone marrow transplant (BMT) for patients with AL, AA and MM for acute Graft-versus-host Disease (GVHD) prophylaxis and treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Graft-versus-host Disease, Relapse
- What is being tested?
- Mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2007to Oct 2014
- Phase
- Phase 2
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- allogenic BMT from related or unrelated donor
Who cannot join
- Severe infection
- Relapse
- admission to ICU
- refusal of research
- patients with graft failure
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
BMT department
Moscow
Elena Parovichnikova, Prof MD PhD, +79161487131, kuzlara@rambler.ru
Elena Parovichnikova
About this study
Official title: Pilot Study for Safety and Effectiveness Assessment of Bone Marrow Mesenchymal Stem Cell Infusion for Acute Graft-versus-host Disease Prophylaxis and Treatment After Allogenic Bone Marrow Transplantation
Infusion of Mesenchymal Stem Cell (MSC) at day of recovery after bone marrow transplant (BMT) for patients with AL, AA and MM for acute Graft-versus-host Disease (GVHD) prophylaxis and treatment.
Read the detailed description
Infusion of mesenchymal stem cells at day of recovery after BMT for patients with AL, AA and MM for acute GVHD prophylaxis and treatment. Infusion at dose 1 cells mln/kg at day of white blood cells recovery.
- Conditions
- Graft-versus-host Disease, Relapse
- Being tested
- Mesenchymal stem cells
- Keywords
- GVHD, Relapse, Overall Survival
- Medical subject headings
- Graft vs Host Disease, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cellsBiological
Also called Mesenchymal stem cells infusion
Mesenchymal stem cells infusion
| Study group | Role | What they receive |
|---|---|---|
| With MSC | Experimental | infusion of Mesenchymal stem cells at dose 1 mln cells per kg Receives: Biological: Mesenchymal stem cells |
| Without MSC | No intervention | Without MSC infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
GVHD
Measured: Every 30 day for 1 year after BMT
Secondary outcomes (3)
Overall survival
Measured: Every 30 day for 1 year after BMT
Relapse-free survival
Measured: Every 30 day for 1 year after BMT
Infection rate
Measured: Every 30 day for 1 year after BMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startOct 2007
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (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 Graft-versus-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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Center for Hematology, Russia
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Elena N.Parovichnikova, National Research Center for Hematology, Russia
- Investigators
- Elena Parovichnikova, Prof MD PhD, Principal investigator, National Research Center for Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941394
- Sponsor's protocol ID
- NRCH-MSC
- Status last verified
- Sep 2013
- First submitted
- 30 Aug 2013
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kuzmina LA, Petinati NA, Parovichnikova EN, Lubimova LS, Gribanova EO, Gaponova TV, Shipounova IN, Zhironkina OA, Bigildeev AE, Svinareva DA, Drize NJ, Savchenko VG. Multipotent Mesenchymal Stromal Cells for the Prophylaxis of Acute Graft-versus-Host Disease-A Phase II Study. Stem Cells Int. 2012;2012:968213. doi: 10.1155/2012/968213. Epub 2011 Dec 25.
PubMed 22242033Petinati N, Davydova Y, Nikiforova K, Bigildeev A, Belyavsky A, Arapidi G, Drize N, Kuzmina L, Parovichnikova E, Savchenko V. T Cell and Cytokine Dynamics in the Blood of Patients after Hematopoietic Stem Cell Transplantation and Multipotent Mesenchymal Stromal Cell Administration. Transplant Cell Ther. 2023 Feb;29(2):109.e1-109.e10. doi: 10.1016/j.jtct.2022.10.030. Epub 2022 Nov 11.
PubMed 36372356
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Safety and Effectiveness Assessment of Bone Marrow Mesenchymal Stem Cell Infusion for Acute Graft-versus-host Disease Prophylaxis and Treatment After Allogenic Bone Marrow Transplantation
- ClinicalTrials.gov ID
- NCT01941394
- Acronym / sponsor ID
- NRCH-MSC
- Conditions
- Graft-versus-host Disease, Relapse
- Keywords
- GVHD, Relapse, Overall Survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Research Center for Hematology, RussiaResearch network
- Study start
- Oct 2007
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 13 Sep 2013 (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.
Infusion of Mesenchymal Stem Cell (MSC) at day of recovery after bone marrow transplant (BMT) for patients with AL, AA and MM for acute Graft-versus-host Disease (GVHD) prophylaxis and treatment.
Detailed description
Infusion of mesenchymal stem cells at day of recovery after BMT for patients with AL, AA and MM for acute GVHD prophylaxis and treatment. Infusion at dose 1 cells mln/kg at day of white blood cells recovery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With MSC | Experimental | Biological: Mesenchymal stem cellsinfusion of Mesenchymal stem cells at dose 1 mln cells per kg |
| Without MSC | No intervention | –Without MSC infusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- allogenic BMT from related or unrelated donor
Key exclusion criteria (5 listed)
- Severe infection
- Relapse
- admission to ICU
- refusal of research
- patients with graft failure
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 stem cellsAlso: Mesenchymal stem cells infusionMesenchymal stem cells infusion | Biological | With MSC |
Primary outcome
GVHD
Time frame: Every 30 day for 1 year after BMT
3 secondary outcomes
Overall survival
Time frame: Every 30 day for 1 year after BMT
Relapse-free survival
Time frame: Every 30 day for 1 year after BMT
Infection rate
Time frame: Every 30 day for 1 year after BMT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2013.
- Results publication: PubMed 22242033Kuzmina LA, Petinati NA, Parovichnikova EN, Lubimova LS, Gribanova EO, Gaponova TV, Shipounova IN, Zhironkina OA, Bigildeev AE, Svinareva DA, Drize NJ, Savchenko VG. Multipotent Mesenchymal Stromal Cells for the Prophylaxis of Acute Graft-versus-Host Disease-A Phase II Study. Stem Cells Int. 2012;2012:968213. doi: 10.1155/2012/968213. Epub 2011 Dec 25.
- Derived from this study: PubMed 36372356Petinati N, Davydova Y, Nikiforova K, Bigildeev A, Belyavsky A, Arapidi G, Drize N, Kuzmina L, Parovichnikova E, Savchenko V. T Cell and Cytokine Dynamics in the Blood of Patients after Hematopoietic Stem Cell Transplantation and Multipotent Mesenchymal Stromal Cell Administration. Transplant Cell Ther. 2023 Feb;29(2):109.e1-109.e10. doi: 10.1016/j.jtct.2022.10.030. Epub 2022 Nov 11.
Related trials for Graft-versus-host Disease
Active, not recruitingPhase 2
De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis
Graft-versus-host Disease
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
RecruitingPhase 1/2
The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation
Peripheral Blood Stem Cell Transplantation, Hematopoietic Stem Cell Transplantation
RecruitingPhase 1/2
Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Graft vs Host Disease
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.
Elena Parovichnikova, Prof MD PhD principal investigator
National Research Center for Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesenchymal stem cells in people with Graft-versus-host Disease and Relapse, run by National Research Center for Hematology, Russia at 1 site in Russia.
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 1 inclusion and 5 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 13 Sep 2013. 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 Russia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Elena Parovichnikova, Prof MD PhD (+79161252623, elenap@blood.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GVHD (time frame: Every 30 day for 1 year after BMT). 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 NCT01941394, 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 13 Sep 2013.