Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation for Type 1 Diabetes With Diabetic Ketoacidosis

The Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation to Treat New-onset Type 1 Diabetes With Diabetic Ketoacidosis

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02763423

Acronym

UCMSCDKA

Enrollment

Registered

2016-05-05

Start date

2009-01-31

Completion date

2019-12-31

Last updated

2016-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ketoacidosis, Diabetic

Keywords

umbilical cord stem cell, diabetic ketoacidosis

Brief summary

This is a phase II trial in individuals who have been diagnosed with type 1 diabetes within the previous 12 months and suffered from diabetic ketoacidosis at onset of disease. The purpose of this study is to determine whether allogeneic umbilical cord mesenchymal stem cell transplantation is effective in the treatment of patients with severe type 1 diabetes.

Detailed description

To assess the clinical efficacy of allogeneic umbilical cord mesenchymal stem cell transplantation in the treatment of patients with severe type 1 diabetes, defined as with the history of diabetic ketoacidosis from diagnosis. All the patients are intravenously administrated with single-dose or double-dose umbilical cord mesenchymal stem cell and followed up for 36 months. Clinical and laboratory manifestations are compared before and after transplantation.

Interventions

PROCEDUREumbilical cord mesenchymal stem cell

allogeneic umbilical cord mesenchymal stem cell transplantation by intravenous injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 35 Years

Healthy volunteers

Inclusion criteria

* Type 1 diabetes * Duration of disease less than 12 months from diagnosis * With the history of diabetic ketoacidosis

Exclusion criteria

* Pregnancy * Severe psychiatric disorder * Severe organic impairment(renal,hepatic,cardiac,pulmonary) * Active infectious disease * Previous or present neoplastic disease

Design outcomes

Primary

Measure	Time frame
Changes from baseline exogenous insulin dose at different time points post treatment	1 month, 3 months,6 months, 12 months, 24 months, 36 months

Secondary

Measure	Time frame
C-peptide level	1 month, 3 months, 6 months, 12 months, 24 months, 36 months
HbA1c level	1 month, 3 months, 6 months, 12 months, 24 months, 36 months
titres of islet antigen antibodies	1 month, 3 months, 6 months, 12 months,24 months, 36 months

Countries

China

Contacts

Primary ContactDalong Zhu, MD.PhD.

zhudalong@nju.edu.cn86-25-83106666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026