Stem Cell Therapy for Type 2 Diabetes Mellitus

Cellonis Biotechnology

Status and phase: Unknown; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Biological: mesenchymal stem cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT01142050

Cellonis-CR-2.3

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy and safety in the treatment of Insulin Resistance of Type 2 Diabetes Mellitus with Bone Marrow Mesenchymal Stem Cells.

Full description

• To evaluate the feasibility and safety of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing insulin injection treatments.
• To assess efficacy of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Free will taking part in the study and ability to provide written informed consent;
2. Type 2 diabetes mellitus (as guideline WHO, 1999);
3. Age 18-75 years old，Male/Female;
4. 19≤Body mass index (BMI)≤30㎏/㎡;
5. Fast blood glucose (FBG)≥7.0 mmol/L, and HbAc1≥7％;
6. Intravenous insulin tolerance test（ITT）indicate patient being insulin resistance;
7. Not pregnant or nursing;
8. Negative pregnancy test;
9. Fertile patients will use effective contraception.

Exclusion criteria

1. Severe concurrent medical condition (e.g., serious heart disease, lung disease, or hematopoietic dysfunction, or liver dysfunction, or kidney dysfunction);
2. Active infection requiring treatment;
3. Unexplained febrile illness;
4. Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)