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

NCT ID: NCT02763423

Last Updated: 2016-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Ketoacidosis, Diabetic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

umbilical cord mesenchymal stem cell

Intervention Type PROCEDURE

allogeneic umbilical cord mesenchymal stem cell transplantation by intravenous injection

Interventions

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umbilical cord mesenchymal stem cell

allogeneic umbilical cord mesenchymal stem cell transplantation by intravenous injection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Dalong Zhu

Chief Physician, Professor, Director of Endocrinology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dalong Zhu, MD.PhD.

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Locations

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The affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dalong Zhu, MD.PhD.

Role: CONTACT

86-25-83106666 ext. 61430

Facility Contacts

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Dalong Zhu, MD.PhD.

Role: primary

86-25-83106666 ext. 61430

Jing Lu, PhD.

Role: backup

86-25-83106666 ext. 61431

References

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Zhang W, Ling Q, Wang B, Wang K, Pang J, Lu J, Bi Y, Zhu D. Comparison of therapeutic effects of mesenchymal stem cells from umbilical cord and bone marrow in the treatment of type 1 diabetes. Stem Cell Res Ther. 2022 Aug 8;13(1):406. doi: 10.1186/s13287-022-02974-1.

Reference Type DERIVED
PMID: 35941696 (View on PubMed)

Other Identifiers

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NJGYNFM-SC-02

Identifier Type: -

Identifier Source: org_study_id

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