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Trial record 26 of 226 for:    Recruiting, Not yet recruiting, Available Studies | "informed consent"

Intraosseous Administration of Mesenchymal Stromal Cells for Patients With Graft Failure After Allo-HSCT

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ClinicalTrials.gov Identifier: NCT03389919
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Elena N.Parovichnikova, National Research Center for Hematology, Russia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mesenchymal Stem Cell Transplantation Biological: MSC administration (intraosseal) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EFFECTIVENESS AND SAFETY OF INTRAOSSEOUS ADMINISTRATION OF MESENCHYMAL STORMAL CELLS FOR PRIMARY GRAFT FAILURE AFTER ALLOGENEIC STEM CELL TRANSPLANTATION
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Intervention Details:
  • Biological: MSC administration (intraosseal)
    MSCs will be administered under local anesthesia to the iliac crests after receiving informed consent from the patient.


Primary Outcome Measures :
  1. Engraftment [ Time Frame: 28-day ]
    Engraftment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with primary graft failure after allo-HSCT
  • Available MSC for this patient

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389919


Locations
Russian Federation
BMT department Recruiting
Moscow, Russian Federation
Contact: Elena Parovichnikova, Prof MD PhD    +79161487131    kuzlara@rambler.ru   
Principal Investigator: Elena Parovichnikova         
Sponsors and Collaborators
National Research Center for Hematology, Russia

Responsible Party: Elena N.Parovichnikova, Head of BMT department, National Research Center for Hematology, Russia
ClinicalTrials.gov Identifier: NCT03389919     History of Changes
Other Study ID Numbers: BM-MSC-01
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No