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Safety Study and Therapeutic Effects of Umbilical Cord Blood Treg on Autoimmune Diabetes

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02932826
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Zhiguang Zhou, Second Xiangya Hospital of Central South University

Tracking Information
First Submitted Date  ICMJE October 11, 2016
First Posted Date  ICMJE October 13, 2016
Last Update Posted Date March 24, 2020
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2016)
Number of Participants with Adverse events as a Measure of Safety and Tolerability [ Time Frame: 2 years ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2020)
  • C-peptide [ Time Frame: 2 years ]
    Measure the C-peptide level of participant after treatment
  • Insulin requirement [ Time Frame: 2 years ]
    Measure the Insulin requirement of participant after treatment
  • Blood glucose [ Time Frame: 2 years ]
    Measure the blood glucose level of participant after treatment
  • HbA1c [ Time Frame: 2 years ]
    Measure the HbA1C level of participant after treatment
  • Autoimmune Status [ Time Frame: 2 years ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2016)
  • C-peptide [ Time Frame: 2 years ]
  • Insulin requirement [ Time Frame: 2 years ]
  • Blood glucose [ Time Frame: 2 years ]
  • HbA1c [ Time Frame: 2 years ]
  • Autoimmune Status [ Time Frame: 2 years ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study and Therapeutic Effects of Umbilical Cord Blood Treg on Autoimmune Diabetes
Official Title  ICMJE Phase 1/ Phase 2 Study of the Therapeutic Effect of Ex-vivo Expanded Umbilical Cord Blood Regulatory T Cells on Autoimmune Diabetes
Brief Summary 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.
Detailed Description 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE
  • Biological: Umbilical Cord Blood Regulatory T cells Therapy
    Receive Treg infusion: 1~5*10^6/kg b.w. in 100ml NS
  • Drug: Insulin
    Treated according to routine clinical practice at the discretion of the treating physician
Study Arms  ICMJE
  • Experimental: Treg Treatment + Insulin
    subjects will be treated with Umbilical Cord Blood Regulatory T cells Therapy and insulin according to routine clinical practice at the discretion of the treating physician
    Interventions:
    • Biological: Umbilical Cord Blood Regulatory T cells Therapy
    • Drug: Insulin
  • Active Comparator: Insulin
    subjects will be treated with insulin according to routine clinical practice at the discretion of the treating physician
    Intervention: Drug: Insulin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 11, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Autoimmune diabetes patients are screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards of American Diabetes Association
  2. Diagnosis of Autoimmune Diabetes within 3 years of screening
  3. Between 6 to 60 years of age
  4. Positive for at least one of the anti-islet autoantibodies: GADA, IA2A, ZnT8A
  5. Fasting or postprandial plasma C-peptide more than 200 pmol/L
  6. Written informed consent from the patient or the patient's parents for patients under the age of 18 years

Exclusion Criteria:

  1. Any clinically significant diseases in liver (ALT and AST over 2 times upper normal limit), kidney (Scr over 133umol/L), and heart
  2. Presence of anemia (Hb ≤100g/L), leukopenia (<3.5×10^9/L)
  3. Presence of disorder in coagulation or anticoagulation, or thrombocytopenia (platelets <100×10^9/L)
  4. Presence of acute metabolic disorders; In the case of acute ketone acidosis, with blood ketone over 0.3mmol/L and pH lower than 7.30
  5. Presence of any kind of chronic infection or immune deficiency, including hepatitis B, hepatitis C, HIV, syphilis or tuberculosis
  6. Chronic use of systemic glucocorticoids or other immunosuppressive agents for over 3 months
  7. Any history of malignancy
  8. Female patients who are pregnant or breastfeeding; any female who is unwilling to use a reliable and effective form of contraception for 2 years afer recruitment
  9. Presence of any infectious diseases, including active skin infections, flu, fever, upper or lower respiratory track infections; those who wish to participate in the study should keep the infection under control for at least 1 week before receiving Treg product infusion
  10. Presence of diabetic microvascular or macrovascular diseases
  11. Presence of hypertension
  12. Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zhiguang Zhou, MD/PhD +86-731-85292154 zhouzg@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02932826
Other Study ID Numbers  ICMJE 2015CX009
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhiguang Zhou, Second Xiangya Hospital of Central South University
Study Sponsor  ICMJE Second Xiangya Hospital of Central South University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zhiguang Zhou, MD/PhD Second Xiangya Hospital of Central South University
PRS Account Second Xiangya Hospital of Central South University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP