NCT03389919

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2017

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 4, 2018

Status Verified

December 1, 2017

Enrollment Period

4 years

First QC Date

December 27, 2017

Last Update Submit

December 27, 2017

Conditions

Mesenchymal Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

  • Engraftment

    Engraftment

    28-day

Interventions

MSC administration (intraosseal)BIOLOGICAL

MSCs will be administered under local anesthesia to the iliac crests after receiving informed consent from the patient.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BMT department

Moscow, Russia

RECRUITING

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of BMT department

Study Record Dates

First Submitted

December 27, 2017

First Posted

January 4, 2018

Study Start

January 1, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2022

Last Updated

January 4, 2018

Record last verified: 2017-12

Locations

RU(1)