Umbilical Cord Mesenchymal Stem Cells and Liraglutide in Diabetes Mellitus

NCT ID: NCT01954147

Last Updated: 2014-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-10-31

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SC-GLP-1

Umbilical Cord Mesenchymal Stem Cell Infusion Combined With Liraglutide

Group Type: EXPERIMENTAL

GLP-1

Intervention Type: DRUG

GLP-1 therapy

SC

Intervention Type: BIOLOGICAL

Stem cell infusion

Standard Medical Treatment

Intervention Type: OTHER

Standard Medical Treatment

SC

Umbilical Cord Mesenchymal Stem Cell Infusion

Group Type: EXPERIMENTAL

SC

Intervention Type: BIOLOGICAL

Stem cell infusion

Standard Medical Treatment

Intervention Type: OTHER

Standard Medical Treatment

GLP-1

Liraglutide

Group Type: EXPERIMENTAL

GLP-1

Intervention Type: DRUG

GLP-1 therapy

Standard Medical Treatment

Intervention Type: OTHER

Standard Medical Treatment

Control

Standard Medical Treatment

Group Type: ACTIVE_COMPARATOR

Standard Medical Treatment

Intervention Type: OTHER

Standard Medical Treatment

Interventions

GLP-1

GLP-1 therapy

Intervention Type: DRUG

SC

Stem cell infusion

Intervention Type: BIOLOGICAL

Standard Medical Treatment

Standard Medical Treatment

Intervention Type: OTHER

Other Intervention Names

SMT

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) .

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diabetes Care Center of Nanjing Military Command

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiangjin Xu, Professor

Role: PRINCIPAL_INVESTIGATOR

Diabetes Care Center of Nanjing Millitary Command

Locations

Diabetes Care Center of Nanjing Military Command

Fuzhou, Fujian, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 27143183 (View on PubMed)

Other Identifiers

SC/GLP-1

Identifier Type: -

Identifier Source: org_study_id