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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 14, 2023
Sponsor:
Information provided by (Responsible Party):
Zhiguang Zhou, Second Xiangya Hospital of Central South University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Biological: Umbilical Cord Blood Regulatory T cells Therapy Drug: Insulin Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/ Phase 2 Study of the Therapeutic Effect of Ex-vivo Expanded Umbilical Cord Blood Regulatory T Cells on Autoimmune Diabetes
Study Start Date : October 2016
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 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
Active Comparator: Insulin
subjects will be treated with insulin according to routine clinical practice at the discretion of the treating physician
 Drug: Insulin
Treated according to routine clinical practice at the discretion of the treating physician


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. C-peptide [ Time Frame: 2 years ]
    Measure the C-peptide level of participant after treatment

  2. Insulin requirement [ Time Frame: 2 years ]
    Measure the Insulin requirement of participant after treatment

  3. Blood glucose [ Time Frame: 2 years ]
    Measure the blood glucose level of participant after treatment

  4. HbA1c [ Time Frame: 2 years ]
    Measure the HbA1C level of participant after treatment

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932826


Contacts
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Contact: Zhiguang Zhou, MD/PhD +86-731-85292154 zhouzg@hotmail.com

Locations
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China, Hunan
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University Recruiting
Changsha, Hunan, China, 410011
Contact: Zhiguang Zhou, MD/PhD    86-731-85292154    zhouzg@hotmail.com   
Sponsors and Collaborators
Second Xiangya Hospital of Central South University
Investigators
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Principal Investigator: Zhiguang Zhou, MD/PhD Second Xiangya Hospital of Central South University
More Information
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Publications:

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Responsible Party: Zhiguang Zhou, MD/PhD, Second Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT02932826    
Other Study ID Numbers: 2015CX009
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: March 14, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhiguang Zhou, Second Xiangya Hospital of Central South University:
Autoimmune Diabetes
Umbilical Cord Blood Cell
Regulatory T Lymphocyte
Cell Therapy
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs