NCT02932826

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2016

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

8.7 years

First QC Date

October 11, 2016

Last Update Submit

March 13, 2023

Conditions

Diabetes Mellitus, Type 1

Keywords

Autoimmune DiabetesUmbilical Cord Blood CellRegulatory T LymphocyteCell Therapy

Outcome Measures

Primary Outcomes (1)

  • Number 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.

    2 years

Secondary Outcomes (5)

  • C-peptide

    2 years

  • Insulin requirement

    2 years

  • Blood glucose

    2 years

  • HbA1c

    2 years

  • Autoimmune Status

    2 years

Study Arms (2)

Treg Treatment + Insulin

EXPERIMENTAL

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 TherapyDrug: Insulin

Insulin

ACTIVE COMPARATOR

subjects will be treated with insulin according to routine clinical practice at the discretion of the treating physician

Drug: Insulin

Interventions

Umbilical Cord Blood Regulatory T cells TherapyBIOLOGICAL

Receive Treg infusion: 1\~5\*10\^6/kg b.w. in 100ml NS

Treg Treatment + Insulin
InsulinDRUG

Treated according to routine clinical practice at the discretion of the treating physician

InsulinTreg Treatment + Insulin

Eligibility Criteria

Age6 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • Diagnosis of Autoimmune Diabetes within 3 years of screening
  • Between 6 to 60 years of age
  • Positive for at least one of the anti-islet autoantibodies: GADA, IA2A, ZnT8A
  • Fasting or postprandial plasma C-peptide more than 200 pmol/L
  • Written informed consent from the patient or the patient's parents for patients under the age of 18 years

You may not qualify if:

  • Any clinically significant diseases in liver (ALT and AST over 2 times upper normal limit), kidney (Scr over 133umol/L), and heart
  • Presence of anemia (Hb ≤100g/L), leukopenia (\<3.5×10\^9/L)
  • Presence of disorder in coagulation or anticoagulation, or thrombocytopenia (platelets \<100×10\^9/L)
  • 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
  • Presence of any kind of chronic infection or immune deficiency, including hepatitis B, hepatitis C, HIV, syphilis or tuberculosis
  • Chronic use of systemic glucocorticoids or other immunosuppressive agents for over 3 months
  • Any history of malignancy
  • 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
  • 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
  • Presence of diabetic microvascular or macrovascular diseases
  • Presence of hypertension
  • Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

RECRUITING

Related Publications (3)

  • Milward K, Issa F, Hester J, Figueroa-Tentori D, Madrigal A, Wood KJ. Multiple unit pooled umbilical cord blood is a viable source of therapeutic regulatory T cells. Transplantation. 2013 Jan 15;95(1):85-93. doi: 10.1097/TP.0b013e31827722ed.

    PMID: 23263503BACKGROUND

  • Fan H, Yang J, Hao J, Ren Y, Chen L, Li G, Xie R, Yang Y, Gao F, Liu M. Comparative study of regulatory T cells expanded ex vivo from cord blood and adult peripheral blood. Immunology. 2012 Jun;136(2):218-30. doi: 10.1111/j.1365-2567.2012.03573.x.

    PMID: 22348606BACKGROUND

  • Brunstein CG, Miller JS, Cao Q, McKenna DH, Hippen KL, Curtsinger J, Defor T, Levine BL, June CH, Rubinstein P, McGlave PB, Blazar BR, Wagner JE. Infusion of ex vivo expanded T regulatory cells in adults transplanted with umbilical cord blood: safety profile and detection kinetics. Blood. 2011 Jan 20;117(3):1061-70. doi: 10.1182/blood-2010-07-293795. Epub 2010 Oct 15.

    PMID: 20952687BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Zhiguang Zhou, MD/PhD

    Second Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiguang Zhou, MD/PhD

CONTACT

+86-731-85292154zhouzg@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD/PhD

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 13, 2016

Study Start

October 1, 2016

Primary Completion

June 1, 2025

Study Completion

November 1, 2025

Last Updated

March 14, 2023

Record last verified: 2023-03

Locations

CN(1)