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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03389919
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : January 4, 2018
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
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 ]

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT03389919

Russian Federation
BMT department Recruiting
Moscow, Russian Federation
Contact: Elena Parovichnikova, Prof MD PhD    +79161487131   
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 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