- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03389919
Intraosseous Administration of Mesenchymal Stromal Cells for Patients With Graft Failure After Allo-HSCT
December 27, 2017 updated by: Elena N.Parovichnikova, National Research Center for Hematology, Russia
EFFECTIVENESS AND SAFETY OF INTRAOSSEOUS ADMINISTRATION OF MESENCHYMAL STORMAL CELLS FOR PRIMARY GRAFT FAILURE AFTER ALLOGENEIC STEM CELL TRANSPLANTATION
Multipotent mesenchymal stromal cells (MSCs) participate in the formation of bone marrow niches for hematopoietic stem cells.
Donor MSCs can serve as a source of recovery for niches in patients with graft failure (GF) after allogeneic bone marrow (BM) transplantation.
Since only few MSCs reach the BM after intravenous injection, MSCs were implanted into the iliac spine.
Preliminary results suggest that MSCs participate in the restoration of niches for donor hematopoietic cells or have an immunomodulatory effect, preventing repeated rejection of the graft.
Perhaps intraosseous implantation of MSCs contributes to the success of the second transplantation of hematopoietic stem cells and patient survival.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- 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
-
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All patients with primary graft failure after allo-HSCT
- Available MSC for this patient
Exclusion Criteria:
- N/A
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Engraftment
Time Frame: 28-day
|
Engraftment
|
28-day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this 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 (Actual)
January 1, 2017
Primary Completion (Anticipated)
December 31, 2020
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
December 27, 2017
First Submitted That Met QC Criteria
December 27, 2017
First Posted (Actual)
January 4, 2018
Study Record Updates
Last Update Posted (Actual)
January 4, 2018
Last Update Submitted That Met QC Criteria
December 27, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- BM-MSC-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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 Mesenchymal Stem Cell Transplantation
-
The Methodist Hospital Research InstituteCenter for Cell and Gene Therapy, Baylor College of MedicineRecruitingMesenchymal Stem Cells | Renal TransplantationUnited States
-
Nanfang Hospital of Southern Medical UniversityPeking University People's Hospital; Sun Yat-sen University; Guangzhou First... and other collaboratorsUnknownMesenchymal Stem Cells | Hematological Diseases | Stem Cell Transplantation, Hematopoietic | Poor Graft FunctionChina
-
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
-
Washington University School of MedicineNational Marrow Donor Program; Predictive BioDiagnostics, LLCCompletedHematopoietic Stem Cell Transplantation | Stem Cell Transplantation, Hematopoietic | Transplantation, Hematopoietic Stem CellUnited States
-
University Hospital, GenevaRecruitingAllogeneic Hematopoietic Stem Cell Transplantation | Hematopoietic Stem Cell Transplantation | Autologous Hematopoietic Stem Cell TransplantationSwitzerland
-
Universitaire Ziekenhuizen KU LeuvenUnknownHematopoietic Stem Cell Transplantation | Hematopoietic Stem Cell Transplantation, Allogeneic
-
University of AarhusCompletedMesenchymal Stem Cells
-
National Center for Complementary and Integrative...National Cancer Institute (NCI)CompletedStem Cell Transplantation | Bone Marrow TransplantationUnited States
-
Hongnan MoUnknownHematopoietic Stem Cell Transplantation | Thrombocytopoietin | Hematopoietic Stem Cell MobilizationChina
Clinical Trials on MSC administration (intraosseal)
-
Andalusian Initiative for Advanced Therapies -...Iniciativa Andaluza en Terapias AvanzadasCompletedAmyotrophic Lateral SclerosisSpain
-
Tisch Multiple Sclerosis Research Center of New...Completed
-
AlloCure Inc.St Mark's Hospital Foundation; Intermountain Health Care, Inc.CompletedKidney Tubular Necrosis, AcuteUnited States
-
Hadassah Medical OrganizationCompleted
-
Fu-Sheng WangUnknownHuman Immunodeficiency Virus | Disorder of Immune ReconstitutionChina
-
The Prince Charles HospitalCell and Tissue Therapies Western AustraliaCompletedBronchiolitis Obliterans | Lung TransplantationAustralia
-
National Heart, Lung, and Blood Institute (NHLBI)TerminatedGraft-Versus-Host DiseaseUnited States
-
King Edward Medical UniversityUnknownSkin Pigmentation Over Contour Deformities of Face | Trauma, Rhomberg DiseasePakistan
-
Indonesia UniversityUnknownNon Union Fracture | Metaphyseal Fibrous DefectIndonesia
-
Affiliated Hospital to Academy of Military Medical...UnknownAcute GVH DiseaseChina