NCT02932826

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

Phase 1/ Phase 2 Study of the Therapeutic Effect of Ex-vivo Expanded Umbilical Cord Blood Regulatory T Cells on Autoimmune Diabetes

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Second Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 6 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-10-01
• Primary completion: 2025-06-01
• Completion: 2025-11-01
• First posted: 2016-10-13
• Last updated: 2023-03-14

Locations

1 site across 1 country: China