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Mesenchymal Stem Cells Infusion for aGVHD Prophylaxis Transplantation

NCT ID: NCT01941394

Last Updated: 2013-09-13

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

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2014-10-31

Brief Summary

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Infusion of Mesenchymal Stem Cell (MSC) at day of recovery after bone marrow transplant (BMT) for patients with AL, AA and MM for acute Graft-versus-host Disease (GVHD) prophylaxis and treatment.

Detailed Description

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Infusion of mesenchymal stem cells at day of recovery after BMT for patients with AL, AA and MM for acute GVHD prophylaxis and treatment. Infusion at dose 1 cells mln/kg at day of white blood cells recovery.

Conditions

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Graft-versus-host Disease Relapse

Keywords

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GVHD Relapse Overall Survival

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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With MSC

infusion of Mesenchymal stem cells at dose 1 mln cells per kg

Group Type EXPERIMENTAL

Mesenchymal stem cells

Intervention Type BIOLOGICAL

Mesenchymal stem cells infusion

Without MSC

Without MSC infusion

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mesenchymal stem cells

Mesenchymal stem cells infusion

Intervention Type BIOLOGICAL

Other Intervention Names

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Mesenchymal stem cells infusion

Eligibility Criteria

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Inclusion Criteria

* allogenic BMT from related or unrelated donor

Exclusion Criteria

* Severe infection
* Relapse
* admission to ICU
* refusal of research
* patients with graft failure
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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

Principal Investigators

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Elena Parovichnikova, Prof MD PhD

Role: PRINCIPAL_INVESTIGATOR

National Research Center for Hematology

Locations

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BMT department

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Elena Parovichnikova, Prof MD PhD

Role: CONTACT

Phone: +79161252623

Email: [email protected]

Larisa Kuzmina, MD PhD

Role: CONTACT

Phone: +79161487131

Email: [email protected]

Facility Contacts

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Elena Parovichnikova, Prof MD PhD

Role: primary

References

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Kuzmina LA, Petinati NA, Parovichnikova EN, Lubimova LS, Gribanova EO, Gaponova TV, Shipounova IN, Zhironkina OA, Bigildeev AE, Svinareva DA, Drize NJ, Savchenko VG. Multipotent Mesenchymal Stromal Cells for the Prophylaxis of Acute Graft-versus-Host Disease-A Phase II Study. Stem Cells Int. 2012;2012:968213. doi: 10.1155/2012/968213. Epub 2011 Dec 25.

Reference Type RESULT
PMID: 22242033 (View on PubMed)

Petinati N, Davydova Y, Nikiforova K, Bigildeev A, Belyavsky A, Arapidi G, Drize N, Kuzmina L, Parovichnikova E, Savchenko V. T Cell and Cytokine Dynamics in the Blood of Patients after Hematopoietic Stem Cell Transplantation and Multipotent Mesenchymal Stromal Cell Administration. Transplant Cell Ther. 2023 Feb;29(2):109.e1-109.e10. doi: 10.1016/j.jtct.2022.10.030. Epub 2022 Nov 11.

Reference Type DERIVED
PMID: 36372356 (View on PubMed)

Other Identifiers

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NRCH-MSC

Identifier Type: -

Identifier Source: org_study_id