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Clonal Fetal Mesenchymal Stem Cells (cfMSCs) for the Control of Immune-related Disorders

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03123458
Recruitment Status : Unknown
Verified February 2018 by Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute.
Recruitment status was:  Enrolling by invitation
First Posted : April 21, 2017
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute

Study Description
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Brief Summary:
The primary objectives are to evaluate the safety and efficacy of infusion of the third party fully-characterized clonally derived fetal MSCs (cfMSCs) for the control of severe symptoms associated with acute and chronic immune-related disorders and tissue damage.

Condition or disease Intervention/treatment Phase
Immune Related Disorder Tissue Damage Biological: clonal fetal MSCs Phase 1

Detailed Description:
MSCs have been extensively studied and clinically evaluated for the treatment of autoimmune diseases and graft versus host disease (GVHD) after hematopoietic stem cell transplantation (HSCT). The variable source of MSCs and the lack of consistency of primary tissue-derived MSCs are major obstacles to reliable translational applications of such therapeutic cell products. Fetal tissue-derived clonal MSCs (cfMSCs) have extended expansion potential and express rich levels of various growth factors, and thus can achieve quality consistency. Careful evaluation of fMSCs in clinical studies has not been conducted. Autoimmune diseases involve aberrant immune responses that harm tissues and organs. GVHD is a serious and often fatal problem associated with HSCT. MSCs have immunomodulatory and immunosuppressive effects. In many studies, MSCs have demonstrated promising beneficial effects that reduce severe autoimmune reactions, diminish symptoms of chronic GvHD and therapy-resistant acute GvHD including steroid-resistant GVHD. The safety and therapeutic effects of phenotype and functionally characterized fMSCs still require extensive clinical evaluation. This study aims to assess the safety and the potential beneficial effects of infusion of various dosages of third party fMSCs for the control of severe symptoms associated with acute and chronic immune-related disorders.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clonal Fetal Mesenchymal Stem Cells (cfMSCs) for the Control of Immune-related Disorders
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Single arm, cfMSC to treat immune disorders
cfMSCs treatment
 Biological: clonal fetal MSCs


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: up to one month ]
    Safety of cfMSC infusion acute and prolonged


Secondary Outcome Measures :
  1. Number of participants with reduced symptoms or stabilized conditions after treatment [ Time Frame: after 1 month from fMSC infusion ]
    Short term clinical effects measured by physiological and serological parameters related to the disease condition and symptoms using prepared study assessment table.


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed consent.
  2. No available alternative treatment that can reduce the symptoms

  3. Patients are required to meet the following inclusion criteria:

    • Any patient that has clinically documented abnormal immune or age-related disorders including acute and chronic GVHD. Patients may receive best available treatment for the control of disease symptoms.
    • Patients with symptoms associated with genetic defects or infectious diseases are not eligible.

Exclusion Criteria:

  1. Inability to give informed consent.
  2. Patients with ongoing infection or history of cancer.
  3. Patients with poor clinical conditions with the life expectancy of less than 14 days.
  4. Pregnancy.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03123458


Locations
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China, Beijing
Capital Institute of Pediatrics affiliated Children's hospital
Beijing, Beijing, China, 100020
China, Guangdong
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000
China
Aerospace Center Hospital
Beijing, China, 100049
Sponsors and Collaborators
Shenzhen Geno-Immune Medical Institute
More Information
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Responsible Party: Lung-Ji Chang, President, Shenzhen Geno-Immune Medical Institute
ClinicalTrials.gov Identifier: NCT03123458    
Other Study ID Numbers: GIMI-IRB-17001
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute:
MSC
GVHDs
transplantation