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

NCT ID: NCT03389919

Last Updated: 2018-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mesenchymal Stem Cell Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MSC administration (intraosseal)

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Center for Hematology, Russia

NETWORK

Sponsor Role lead

Responsible Party

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Elena N.Parovichnikova

Head of BMT department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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BMT department

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Facility Contacts

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Elena Parovichnikova, Prof MD PhD

Role: primary

+79161487131

Other Identifiers

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BM-MSC-01

Identifier Type: -

Identifier Source: org_study_id

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