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Trial record 4 of 165 for:    uMBILICAL CORD MESENCHYMAL STEM CELLS

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

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ClinicalTrials.gov Identifier: NCT02763423
Recruitment Status : Recruiting
First Posted : May 5, 2016
Last Update Posted : May 5, 2016
Sponsor:
Information provided by (Responsible Party):
Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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
Ketoacidosis, Diabetic 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : January 2009
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Changes from baseline exogenous insulin dose at different time points post treatment [ Time Frame: 1 month, 3 months,6 months, 12 months, 24 months, 36 months ]

Secondary Outcome Measures :
  1. C-peptide level [ Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months ]
  2. HbA1c level [ Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months ]
  3. titres of islet antigen antibodies [ Time Frame: 1 month, 3 months, 6 months, 12 months,24 months, 36 months ]


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Ages Eligible for Study:   12 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02763423


Contacts
Contact: Dalong Zhu, MD.PhD. 86-25-83106666 ext 61430 zhudalong@nju.edu.cn

Locations
China, Jiangsu
The affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Dalong Zhu, MD.PhD.    86-25-83106666 ext 61430    zhudalong@nju.edu.cn   
Contact: Jing Lu, PhD.    86-25-83106666 ext 61431    qiusnow16@hotmail.com   
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

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     History of Changes
Other Study ID Numbers: NJGYNFM-SC-02
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
umbilical cord stem cell
diabetic ketoacidosis

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Ketosis
Acidosis
Diabetic Ketoacidosis
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Acid-Base Imbalance
Diabetes Complications