The purpose of this study is to investigate the safety and therapeutic effect of ex-vivo expanded umbilical cord blood regulatory T cells on autoimmune diabetes.
The regulatory T cells (Treg) used in this study will be produced from human umbilical cord blood. The umbilical cord blood will be freshly collected and immediately separated to buffy coat in a GMP laboratory, thus to be further sorted into Treg and other subsets. Then the Treg will be expanded ex-vivo for approximately 14 days until tested for its surface markers and suppressive ability. During the time of ex-vivo expansion, eligible autoimmune diabetes patients will be recruited and admitted to our hospital in order to go through required examinations. Once the Treg product has reached the safety and efficacy standards, the patient will receive the Treg product infusion under close surveillance of doctors and then go through regular follow-ups to investigate the safety and therapeutic effect of the Treg product on autoimmune diabetes patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Receive Treg infusion: 1\~5\*10\^6/kg b.w. in 100ml NS
Treated according to routine clinical practice at the discretion of the treating physician
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, Hunan, China
RECRUITINGNumber of Participants with Adverse events as a Measure of Safety and Tolerability
The number of participants with adverse events, laboratory abnormalities and other signs of toxicity. Particular focus will be on the number and severity of infusion reactions, complications related to infection, and any potential negative impact on the course of diabetes.
Time frame: 2 years
C-peptide
Measure the C-peptide level of participant after treatment
Time frame: 2 years
Insulin requirement
Measure the Insulin requirement of participant after treatment
Time frame: 2 years
Blood glucose
Measure the blood glucose level of participant after treatment
Time frame: 2 years
HbA1c
Measure the HbA1C level of participant after treatment
Time frame: 2 years
Autoimmune Status
The autoimmune status refers to the state and degree of autoimmune attacks in autoimmune diabetes patients. Measures include change in titer of autoantibodies, change in subsets of immune cells, and change in autoimmune related cytokines.
Time frame: 2 years
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