- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03631589
MSC for Severe aGVHD
August 13, 2018 updated by: Jianda Hu, Fujian Medical University
Treatment of Steroid-resistant Severe Acute Graft-versus-host Disease With Mesenchymal Stem Cells
Steroid-resistant acute graft-versus-host disease (aGVHD) is one of the most severe complications in the setting of allogeneic hematopoietic stem cell transplantation (HSCT), which cannot be significant benefit from the second-line therapies.The mesenchymal stem cells (MSCs) possess extensive immunomodulatory properties and are very promising to rescue the refractory aGVHD.This study aims to assess the efficacy and safety of MSCs for the treatment of the refractory aGVHD.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350001
- Recruiting
- Fujian Medical University Union Hospital
-
-
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
No older than 65 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed written informed consent
- Aged <65 years
- Patients with steroid-resistant severe aGVHD
- Cardiac: Left ventricular ejection fraction ≥ 50%
- Adequate renal and hepatic function
- Performance status: Karnofsky ≥ 70%
Exclusion Criteria:
- Pregnant or lactating females.
- Any co-morbidity precluding the administration of MSCs.
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: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MSCs treated
|
mesenchymal stem cells therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
complete and partial response rate
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events that are related to treatment
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ACTUAL)
December 1, 2017
Primary Completion (ANTICIPATED)
December 1, 2019
Study Completion (ANTICIPATED)
December 1, 2021
Study Registration Dates
First Submitted
August 13, 2018
First Submitted That Met QC Criteria
August 13, 2018
First Posted (ACTUAL)
August 15, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 15, 2018
Last Update Submitted That Met QC Criteria
August 13, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- MSC-SCT-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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 Steroid-resistant Severe aGVHD
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AbGenomics B.V Taiwan BranchWithdrawnSteroid-refractory aGvHD Subsequent to Allogeneic Hematopoietic Cell TransplantationUnited States
-
Anhui Provincial HospitalRecruitingSteroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)China
-
Seoul National University Childrens HospitalUnknownSteroid Resistant Nephrotic Syndrome | Steroid Dependent Nephrotic SyndromeKorea, Republic of
-
Jonsson Comprehensive Cancer CenterWithdrawnAcute Graft Versus Host Disease | Gastrointestinal Tract Acute Graft Versus Host Disease | Severe Gastrointestinal Tract Acute Graft Versus Host Disease | Steroid Resistant Gastrointestinal Tract Acute Graft Versus Host DiseaseUnited States
-
Novartis PharmaceuticalsAvailablePrimary Myelofibrosis (PMF) | Polycythemia Vera (PV) | Post Polycythemia Myelofibrosis (PPV MF) | Thrombocythemia Myelofibrosis (PET-MF) | Severe/Very Severe COVID-19 Illness | Steroid Refractory Acute Graft Versus Host Disease (SR aGVHD) | Steroid Refractory Chronic Graft Versus Host Disease...
-
ElsaLys BiotechAvailableSteroid Resistant Acute Graft Versus Host DiseaseFrance
-
Assiut UniversityUnknownNephrotic Syndrome Steroid-Resistant
-
Rhode Island HospitalUniversity of Minnesota; Mallinckrodt; MedalyticsWithdrawnSteroid-Resistant Nephrotic Syndrome
-
The Cleveland ClinicCompletedMajor Depressive Disorder | Treatment Resistant Depression | Severe DepressionUnited States
-
Children's National Research InstituteNational Kidney FoundationCompletedFocal Segmental Glomerulosclerosis | Steroid Resistant Nephrotic SyndromeUnited States
Clinical Trials on MSCs
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Chinese Academy of SciencesThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical...UnknownType 2 Diabetes Mellitus | Erectile Dysfunction | Type 1 Diabetes MellitusChina
-
Jas ChahalCompleted
-
First Affiliated Hospital, Sun Yat-Sen UniversitySecond Affiliated Hospital of Guangzhou Medical UniversityUnknownKidney Transplantation | Acute Kidney Tubular NecrosisChina
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Ruijin HospitalCellular Biomedicine Group Ltd.Completed
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Beijing 302 HospitalFifth Affiliated Hospital, Sun Yat-Sen University; Shenzhen Third People's... and other collaboratorsUnknown
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Children's Hospital of Chongqing Medical UniversityUnknownBronchopulmonary DysplasiaChina
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Emory UniversityNational Heart, Lung, and Blood Institute (NHLBI)Withdrawn
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Alexandra Cristina SenegagliaFundação Araucária; Santa Casa de Misericórdia de Curitiba, BrazilCompleted
-
Chinese Academy of SciencesAffiliated Hospital of Logistics University of CAPFUnknown