Tissue Damage Clinical Trial
Official title:
Clonal Fetal Mesenchymal Stem Cells (cfMSCs) for the Control of Immune-related Disorders
Verified date | February 2018 |
Source | Shenzhen Geno-Immune Medical Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 100 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Aerospace Center Hospital | Beijing | |
China | Capital Institute of Pediatrics affiliated Children's hospital | Beijing | Beijing |
China | Shenzhen Geno-immune Medical Institute | Shenzhen | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Shenzhen Geno-Immune Medical Institute |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Safety of cfMSC infusion acute and prolonged | up to one month | |
Secondary | Number of participants with reduced symptoms or stabilized conditions after treatment | 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 |
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