Co-transplantation of MSC in the Setting of Allo-HSCT

NCT ID: NCT04247945

Last Updated: 2020-01-30

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

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2025-12-01

Brief Summary

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Mesenchymal stem cells (MSCs) are known to exhibit immunomodulatory, anti-inflammatory, and pro-angiogenic properties, and therefore have the potential to improve the outcome of allogeneic hematopoietic stem cell transplantation (allo-HSCT) .The study is aimed to identify and evaluate the potential benefits of MSCs infusion during allogeneic HSCT, with regard to the engraftment, graft versus host disease (GVHD), post-transplant relapse and survival.

Detailed Description

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Conditions

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Allogeneic Hematopoietic Stem Cell Transplantation

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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HSC

Group Type NO_INTERVENTION

No interventions assigned to this group

MSC+HSC

Group Type EXPERIMENTAL

Cotransplant with MSCs

Intervention Type BIOLOGICAL

Co-transplantation of MSCs during allogeneic HSCT

Interventions

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Cotransplant with MSCs

Co-transplantation of MSCs during allogeneic HSCT

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Signed written informed consent
* Aged \<65 years
* Willing to transplant
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria

* Pregnant or lactating females.
* Any co-morbidity precluding the administration of MSCs.
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ting YANG

Professor of Hematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Union Hospital,Fujian Medical University

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ting Yang, Prof.

Role: CONTACT

+86-591-86218041

Facility Contacts

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Ting Yang, Prof.

Role: primary

+86-591-86218041

Jianda Hu, Prof.

Role: backup

+86-591-86218041

Other Identifiers

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MSC-SCT-03

Identifier Type: -

Identifier Source: org_study_id

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