Stem Cell Therapy for Type 1 Diabetes Mellitus

NCT01143168 | Unknown Phase 1 DMC

• 1 other identifier: Cellonis-CR-1.3
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 1 Diabetes Mellitus

Keywords

stem cells;; diabetes mellitus;; treatment.

Outcome Measures

Primary Outcomes (1)

• Rate of reducing exogenous insulin requirement; Hemoglobin A1c; Fast blood glucose (FBG) and postmeal blood glucose (PBG); C-peptide levels.

  Rate of reducing exogenous insulin requirement compared with baseline. Hemoglobin A1c. Fast blood glucose (FBG) and postmeal blood glucose (PBG). C-peptide levels.

  1 year

Secondary Outcomes (1)

• Serious adverse event frequency and severity

  1 year

Interventions

autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells BIOLOGICAL

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Free will taking part in the study and ability to provide written informed consent.
• Confirmed diagnosis of type I diabetes for at least 2 years
• Insulin-dependent.
• Age 18-50 years, Male/Female.
• FBG≥7.0 mmol/L, and HbAc1≥7％.
• Not pregnant or nursing.
• Negative pregnancy test.
• Fertile patients will use effective contraception.

You may not qualify if:

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

Sponsors & Collaborators

• Cellonis Biotechnology Co. Ltd.: lead

Study Sites (1)

Armed Police General Hospital, P. R. China

Beijing, 100085, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Shi X Y, M.D.

  Armed Police General Hospital, P. R. China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: June 14, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 14, 2010

Record last verified: 2010-06

Locations

CN (1)