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

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)
Overall Status
Unknown status
CT.gov ID
NCT02763423
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
131
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: umbilical cord mesenchymal stem cell
 Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation to Treat New-onset Type 1 Diabetes With Diabetic Ketoacidosis
Study Start Date :
Jan 1, 2009
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: umbilical cord mesenchymal stem cell

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

Procedure: umbilical cord mesenchymal stem cell
allogeneic umbilical cord mesenchymal stem cell transplantation by intravenous injection

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. C-peptide level [1 month, 3 months, 6 months, 12 months, 24 months, 36 months]

  2. HbA1c level [1 month, 3 months, 6 months, 12 months, 24 months, 36 months]

  3. titres of islet antigen antibodies [1 month, 3 months, 6 months, 12 months,24 months, 36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Nanjing Jiangsu China 210008

Sponsors and Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

  • Principal Investigator: Dalong Zhu, MD.PhD., The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dalong Zhu, Chief Physician, Professor, Director of Endocrinology Department, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier:
NCT02763423
Other Study ID Numbers:
  • NJGYNFM-SC-02
First Posted:
May 5, 2016
Last Update Posted:
May 5, 2016
Last Verified:
May 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Dalong Zhu, Chief Physician, Professor, Director of Endocrinology Department, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
umbilical cord stem cell
diabetic ketoacidosis
Additional relevant MeSH terms:
Ketosis
Acidosis
Diabetic Ketoacidosis

Study Results

No Results Posted as of May 5, 2016