Clonal Fetal Mesenchymal Stem Cells (cfMSCs) for the Control of Immune-related Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: clonal fetal MSCs.
- Who it may be relevant to
- Registry conditions: Immune Related Disorder, Tissue Damage. Basic parameters: 1 year — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- Biological clonal fetal MSCs
clonal fetal MSCs
Primary outcome measures
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time frame: up to one month]
Secondary outcome measures (1)
- Number of participants with reduced symptoms or stabilized conditions after treatment [Time frame: after 1 month from fMSC infusion]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shenzhen Geno-immune Medical Institute — Shenzhen
Identifiers
NCT: NCT03123458 · GIMI-IRB-17001