Stem Cell Therapy for Type 2 Diabetes Mellitus

NCT ID: NCT01142050

Last Updated: 2010-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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* 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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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mesenchymal stem cells

1.1st transplantation: after finishing all required examines according to protocol in Day 0, ABM-MSCs are transplanted through pancreas artery percutaneously; 2. 2nd transplantation: after finishing all required examines in Day 7±1, BM-MSCs are transplanted intravenously; 3. 3rd transplantation: after finishing all required examines in Day 14±2, BM-MSCs are transplanted intravenously.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cellonis Biotechnology Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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others

Locations

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Armed Police General Hospital, P.R. China

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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Cellonis-CR-2.3

Identifier Type: -

Identifier Source: org_study_id

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