Umbilical Cord Mesenchymal Stem Cells and Liraglutide in Diabetes Mellitus
1 other identifier
interventional
100
1 country
1
Brief Summary
Umbilical cord mesenchymal stem cells (SC) transplantation was a novel therapy for diabetes mellitus, with less side effects and more advantages. Clinical trials had verified that good metabolic control would be achieved when Liraglutide (GLP-1) was added to the conventional therapies. The investigators hypothesized that the combined therapy of umbilical cord mesenchymal stem cells transplantation and Liraglutide in type 2 diabetes mellitus will aid the differentiation of stem cells into insulin-producing cells, improve the survival of differentiated cells, protect the residual beta-cells and improve insulin secreting function, so as to achieve a favorable glucose homeostasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 type-2-diabetes
Started Oct 2013
Longer than P75 for phase_1 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2013
CompletedFirst Posted
Study publicly available on registry
October 1, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFebruary 20, 2014
February 1, 2014
1 year
August 13, 2013
February 19, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1C
1 year
Secondary Outcomes (1)
Fasting Blood Glucose
1 year
Study Arms (4)
SC-GLP-1
EXPERIMENTALUmbilical Cord Mesenchymal Stem Cell Infusion Combined With Liraglutide
SC
EXPERIMENTALUmbilical Cord Mesenchymal Stem Cell Infusion
GLP-1
EXPERIMENTALLiraglutide
Control
ACTIVE COMPARATORStandard Medical Treatment
Interventions
Eligibility Criteria
You may qualify if:
- Male and female patients age 35 to 65 years of age.
- Ability to provide written informed consent.
- Mentally stable and able to comply with the procedures of the study protocol.
- Clinical history compatible with type 2 diabetes (T2DM) as defined by ADA(1997) on the Diagnosis and classification of Diabetes Mellitus
- Basal C-peptide 0.5-2.0 ng/mL
- HbA1c ≥ 7.5 and ≤ 11% before standard medical therapy (SMT).
- Patients must have been treated with SMT for 1-4 months prior to matching. Insulin dose and metformin doses should be stable over 1 month prior to matching.
- HbA1c ≥ 7.5 and ≤ 10% at time of matching.
- Total insulin daily dose (TDD) at time of matching should not exceed 1.0 units/day/kg
- kg/㎡≤BMI≤40.0kg/㎡
You may not qualify if:
- Abnormal liver function \>2.5 x ULN
- Evidence of renal dysfunction:serum creatinine \> 1.5 mg/dl (males) and 1.3 mg/dl (females).
- Gastrointestinal operation history.
- Type 1 Diabetes mellitus; DKA; secondary diabetes.
- Uncontrolled blood Pressure: SBP \>180 mmHg or DBP \>100 mmHg at the time of matching.
- Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months.
- Presence of active proliferative diabetic retinopathy or macular edema.
- Any acute or chronic infectious condition that in the criteria of the investigator would be a risk for the patient.
- For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study. For male participants: intent to procreate 3 months before or after the intervention or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant?, Depo-Provera?, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.
- Active infection including hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.
- Subjects that are being treated with any medication that could interfere with the outcome of the study such as: Thiazolidinediones and other glucagon like peptide 1 (GLP-1) analogues (Exenatide, Byetta), Pramlintide (Amylin), Dipeptidyl-peptidase IV (DPP-IV) inhibitors (i.e. Sitagliptin, Januvia)
- Any known or suspected allergy to liraglutide or other relevant products.
- Evidence of thyroid adverse events (serum calcitonin increase, goiter, thyroid cancer, et al) or pancreatitis caused by other GLP-1 analogues.
- Subjects with past history or family history of Medullary Thyroid Carcinoma(MTC) or Multiple Endocrine Neoplasia Syndrome Type 2(MEN2) .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diabetes Care Center of Nanjing Military Command
Fuzhou, Fujian, 350025, China
Related Publications (1)
Chen P, Huang Q, Xu XJ, Shao ZL, Huang LH, Yang XZ, Guo W, Li CM, Chen C. [The effect of liraglutide in combination with human umbilical cord mesenchymal stem cells treatment on glucose metabolism and beta cell function in type 2 diabetes mellitus]. Zhonghua Nei Ke Za Zhi. 2016 May 1;55(5):349-54. doi: 10.3760/cma.j.issn.0578-1426.2016.05.004. Chinese.
PMID: 27143183DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiangjin Xu, Professor
Diabetes Care Center of Nanjing Millitary Command
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2013
First Posted
October 1, 2013
Study Start
October 1, 2013
Primary Completion
October 1, 2014
Study Completion
October 1, 2015
Last Updated
February 20, 2014
Record last verified: 2014-02