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MSC for Severe aGVHD

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: NCT03631589
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : August 15, 2018
Information provided by (Responsible Party):
Jianda Hu, Fujian Medical University

Brief Summary:
Steroid-resistant acute graft-versus-host disease (aGVHD) is one of the most severe complications in the setting of allogeneic hematopoietic stem cell transplantation (HSCT), which cannot be significant benefit from the second-line therapies.The mesenchymal stem cells (MSCs) possess extensive immunomodulatory properties and are very promising to rescue the refractory aGVHD.This study aims to assess the efficacy and safety of MSCs for the treatment of the refractory aGVHD.

Condition or disease Intervention/treatment Phase
Steroid-resistant Severe aGVHD Biological: MSCs Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Steroid-resistant Severe Acute Graft-versus-host Disease With Mesenchymal Stem Cells
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2021

Arm Intervention/treatment
Experimental: MSCs treated Biological: MSCs
mesenchymal stem cells therapy

Primary Outcome Measures :
  1. complete and partial response rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Adverse events that are related to treatment [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed written informed consent
  • Aged <65 years
  • Patients with steroid-resistant severe aGVHD
  • 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.

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): NCT03631589

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Contact: Jianda Hu, Prof.M.D.Ph.D 86-13959169016

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China, Fujian
Fujian Medical University Union Hospital Recruiting
Fuzhou, Fujian, China, 350001
Contact: Jianda Hu, Prof.    86-13959169016   
Contact: Ting Yang, Prof.    86-13950210357   
Principal Investigator: Jianda Hu, Prof.         
Sponsors and Collaborators
Fujian Medical University

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Responsible Party: Jianda Hu, Director of the department of Hematology, Fujian Medical University Identifier: NCT03631589     History of Changes
Other Study ID Numbers: MSC-SCT-01
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No