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

Nanjing University

Status and phase: Unknown; Phase 2

Conditions: Ketoacidosis, Diabetic

Treatments: Procedure: umbilical cord mesenchymal stem cell

Study type: Interventional

Funder types: Other

Identifiers

NCT02763423

NJGYNFM-SC-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 12 to 35 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

umbilical cord mesenchymal stem cell

Experimental group

Description:

single- or double-dose intravenous injection of umbilical cord mesenchymal stem cells for the treatment of severe type 1 diabetes patients

Treatment:

Procedure: umbilical cord mesenchymal stem cell