Clonal Fetal Mesenchymal Stem Cells (cfMSCs) for the Control of Immune-related Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Important Regulatory Notice:
This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China.
ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities.
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 Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Lung-Ji Chang, PhD
- Phone Number: +86 0755-86573763
- Email: c@szgimi.org
Study Contact Backup
- Name: Jiengong Wei, MD
- Phone Number: +86 0755-86573763
- Email: WJG1228@163.COM
Study Locations
-
-
Guangdong
-
Shenzhen, Guangdong, China, 518000
- Shenzhen Geno-immune Medical Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Informed consent.
- No available alternative treatment that can reduce the symptoms
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:
- Inability to give informed consent.
- Patients with ongoing infection or history of cancer.
- Patients with poor clinical conditions with the life expectancy of less than 14 days.
- Pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single arm, cfMSC to treat immune disorders
cfMSCs treatment
|
clonal fetal MSCs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
up to one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
after 1 month from fMSC infusion
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIMI-IRB-17001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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