- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01941394
Mesenchymal Stem Cells Infusion for aGVHD Prophylaxis Transplantation
September 12, 2013 updated by: Elena N.Parovichnikova, National Research Center for Hematology, Russia
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.
Study Overview
Status
Unknown
Conditions
Intervention / 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 Type
Interventional
Enrollment (Anticipated)
70
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Elena Parovichnikova, Prof MD PhD
- Phone Number: +79161252623
- Email: elenap@blood.ru
Study Contact Backup
- Name: Larisa Kuzmina, MD PhD
- Phone Number: +79161487131
- Email: kuzlara@rambler.ru
Study Locations
-
-
-
Moscow, Russian Federation
- Recruiting
- BMT department
-
Contact:
- Elena Parovichnikova, Prof MD PhD
- Phone Number: +79161487131
- Email: kuzlara@rambler.ru
-
Principal Investigator:
- Elena Parovichnikova
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- allogenic BMT from related or unrelated donor
Exclusion Criteria:
- Severe infection
- Relapse
- admission to ICU
- refusal of research
- patients with graft failure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: With MSC
infusion of Mesenchymal stem cells at dose 1 mln cells per kg
|
Mesenchymal stem cells infusion
Other Names:
|
No Intervention: Without MSC
Without MSC infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
GVHD
Time Frame: Every 30 day for 1 year after BMT
|
Every 30 day for 1 year after BMT
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: Every 30 day for 1 year after BMT
|
Every 30 day for 1 year after BMT
|
Relapse-free survival
Time Frame: Every 30 day for 1 year after BMT
|
Every 30 day for 1 year after BMT
|
Infection rate
Time Frame: Every 30 day for 1 year after BMT
|
Every 30 day for 1 year after BMT
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Elena Parovichnikova, Prof MD PhD, National Research Center for Hematology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Anticipated)
October 1, 2014
Study Completion (Anticipated)
October 1, 2014
Study Registration Dates
First Submitted
August 30, 2013
First Submitted That Met QC Criteria
September 12, 2013
First Posted (Estimate)
September 13, 2013
Study Record Updates
Last Update Posted (Estimate)
September 13, 2013
Last Update Submitted That Met QC Criteria
September 12, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NRCH-MSC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Relapse
-
Centre Hospitalier Henri LaboritRecruiting
-
Cairo UniversityNot yet recruiting
-
Poliklinika OrthonovaUniversity of Zagreb School of Dental Medicine, Zagreb, Croatia; University...RecruitingOrthodontic RelapseCroatia
-
Sydney Local Health DistrictRecruiting
-
University of MinnesotaNational Institute on Drug Abuse (NIDA)Recruiting
-
Care Team SolutionsCompleted
-
Yale UniversityNational Institute on Minority Health and Health Disparities (NIMHD)CompletedPostpartum Smoking RelapseUnited States
-
Semra YILMAZCompletedPostpartum Smoking RelapseTurkey
-
University of DelawareDelaware Department of Probation & ParoleUnknownRecidivism | Probationary Failure | Drug RelapseUnited States
-
Maastricht University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development; Nabi...CompletedSmoking Behavior | Smoking Lapse Behavior | Smoking Relapse BehaviorNetherlands
Clinical Trials on Mesenchymal stem cells
-
Guangzhou General Hospital of Guangzhou Military...UnknownSpinal Cord InjuryChina
-
Guangzhou General Hospital of Guangzhou Military...Guangzhou Municipal Twelfth People's Hospital; Guangdong Prevention and Treatment...Unknown
-
Guangzhou General Hospital of Guangzhou Military...UnknownParkinson's DiseaseChina
-
Hospital ZnojmoUnknown
-
University College, LondonUnknownTendinopathy | Achilles Tendinitis | Achilles Degeneration | Achilles Tendinitis, Right Leg | Achilles Tendon Thickening | Achilles Tendinitis, Left LegUnited Kingdom
-
Qingdao UniversityUnknownDilated CardiomyopathyChina
-
Qingdao UniversityUnknownUlcerative Colitis | Mesenchymal Stem Cells | Umbilical CordChina
-
Qingdao UniversityUnknownDiabetes Mellitus | Diabetes Mellitus, Type 1 | Mesenchymal Stem Cells | Umbilical CordChina
-
Universidad Catolica Santiago de GuayaquilMaastricht University Medical CenterUnknownOsteo Arthritis KneeEcuador
-
Nanfang Hospital of Southern Medical UniversityPeking University People's Hospital; Sun Yat-sen University; Guangzhou First... and other collaboratorsUnknownMesenchymal Stem Cells | Hematopoietic Stem Cell Transplantation | Hematological Diseases | Graft Failure | Umbilical Cord BloodChina