Clinical trial NCT01954147: Umbilical Cord Mesenchymal Stem Cells and Liraglutide in Diabetes Mellitus
Official title: Umbilical Cord Mesenchymal Stem Cell Infusion With Liraglutide in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Diabetes Care Center of Nanjing Military Command
Sponsor class: OTHER
First posted: 2013-10-01
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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) .

Primary outcomes:
measure: HbA1C
timeFrame: 1 year
Secondary outcomes:
measure: Fasting Blood Glucose
timeFrame: 1 year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Diabetes Care Center of Nanjing Military Command
state: Fujian
Study officials:
affiliation: Diabetes Care Center of Nanjing Millitary Command
name: Xiangjin Xu, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.