Umbilical Cord Mesenchymal Stem Cells and Liraglutide in Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01954147
• Other study ID #: SC/GLP-1
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: August 13, 2013
• Last updated: February 19, 2014
• Start date: October 2013
• Est. completion date: October 2015

Study information

• Verified date: February 2014
• Source: Diabetes Care Center of Nanjing Military Command
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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) .

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• GLP-1
GLP-1 therapy

Biological:
• SC
Stem cell infusion

Other:
• Standard Medical Treatment
Standard Medical Treatment

Locations

Country	Name	City	State
China	Diabetes Care Center of Nanjing Military Command	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Diabetes Care Center of Nanjing Military Command

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1C		1 year	No
Secondary	Fasting Blood Glucose		1 year	No