Stem Cell Therapy for Type 1 Diabetes Mellitus

NCT ID: NCT01143168

Last Updated: 2010-06-14

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 this study is to evaluate the feasibility, efficacy and safety of transplantation therapy using bone marrow mononuclear cells and umbilical cord mesenchymal stem cells for patients with type 1 diabetes mellitus

Detailed Description

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To evaluate the feasibility, safety and efficacy of transplantation using autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells in patients with type 1 diabetes mellitus.

Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells

First Transplantation: after finishing all required examines according to protocol on Day 0, ABM-MNCs + UCMSCs are transplanted through pancreas artery percutaneously; Second Transplantation: after finishing all required examines on Day 7±1, BM-MNCs UCMSCs are transplanted intravenously; Third Transplantation: after finishing all required examines on Day 14±2, BM-MNCs + UCMSCs 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. Confirmed diagnosis of type I diabetes for at least 2 years
3. Insulin-dependent.
4. Age 18-50 years, Male/Female.
5. FBG≥7.0 mmol/L, and HbAc1≥7%.
6. Not pregnant or nursing.
7. Negative pregnancy test.
8. Fertile patients will use effective contraception.

Exclusion Criteria

1. Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.
2. Severe concurrent medical condition (e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).
3. Active infection requiring treatment.
4. Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 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

Principal Investigators

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Shi X Y, M.D.

Role: PRINCIPAL_INVESTIGATOR

Armed Police General Hospital, P. R. China

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-1.3

Identifier Type: -

Identifier Source: org_study_id

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