Umbilical Cord Mesenchymal Stem Cells and Liraglutide in Diabetes Mellitus

Sponsor

Diabetes Care Center of Nanjing Military Command (Other)

Overall Status

Unknown status

CT.gov ID

NCT01954147

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: GLP-1 Biological: SC Other: Standard Medical Treatment	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Umbilical Cord Mesenchymal Stem Cell Infusion With Liraglutide in Type 2 Diabetes Mellitus

Study Start Date :

Oct 1, 2013

Anticipated Primary Completion Date :

Oct 1, 2014

Anticipated Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SC-GLP-1 Umbilical Cord Mesenchymal Stem Cell Infusion Combined With Liraglutide	Drug: GLP-1 GLP-1 therapy Biological: SC Stem cell infusion Other: Standard Medical Treatment Standard Medical Treatment Other Names: SMT
Experimental: SC Umbilical Cord Mesenchymal Stem Cell Infusion	Biological: SC Stem cell infusion Other: Standard Medical Treatment Standard Medical Treatment Other Names: SMT
Experimental: GLP-1 Liraglutide	Drug: GLP-1 GLP-1 therapy Other: Standard Medical Treatment Standard Medical Treatment Other Names: SMT
Active Comparator: Control Standard Medical Treatment	Other: Standard Medical Treatment Standard Medical Treatment Other Names: SMT

Outcome Measures

Primary Outcome Measures

HbA1C [1 year]

Secondary Outcome Measures

Fasting Blood Glucose [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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
18.5 kg/㎡≤BMI≤40.0kg/㎡

Exclusion Criteria:

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) .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diabetes Care Center of Nanjing Military Command	Fuzhou	Fujian	China	350025

Sponsors and Collaborators

Diabetes Care Center of Nanjing Military Command

Investigators

Principal Investigator: Xiangjin Xu, Professor, Diabetes Care Center of Nanjing Millitary Command

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Diabetes Care Center of Nanjing Military Command

ClinicalTrials.gov Identifier:

NCT01954147

Other Study ID Numbers:

SC/GLP-1

First Posted:

Oct 1, 2013

Last Update Posted:

Feb 20, 2014

Last Verified:

Feb 1, 2014

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Feb 20, 2014