Stem Cell Therapy for Type 1 Diabetes Mellitus

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified June 2010 by Cellonis Biotechnology Co. Ltd..
Recruitment status was: Not yet recruiting

Sponsor:

Information provided by:

Cellonis Biotechnology Co. Ltd.

ClinicalTrials.gov Identifier:

NCT01143168

First received: June 10, 2010

Last updated: June 11, 2010

Last verified: June 2010

History of Changes

Purpose

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

Condition	Intervention	Phase
Type 1 Diabetes Mellitus	Biological: autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Pilot Study on Transplantation Therapy Using Autologous Bone Marrow Mononuclear Cells and Umbilical Cord Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Type 1

U.S. FDA Resources

Further study details as provided by Cellonis Biotechnology Co. Ltd.:

Primary Outcome Measures:

Rate of reducing exogenous insulin requirement; Hemoglobin A1c; Fast blood glucose (FBG) and postmeal blood glucose (PBG); C-peptide levels. [ Time Frame: 1 year ]
Rate of reducing exogenous insulin requirement compared with baseline. Hemoglobin A1c. Fast blood glucose (FBG) and postmeal blood glucose (PBG). C-peptide levels.

Secondary Outcome Measures:

Serious adverse event frequency and severity [ Time Frame: 1 year ]


Estimated Enrollment:	24
Study Start Date:	August 2010
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143168

Locations


China
Armed Police General Hospital, P. R. China	Not yet recruiting
Beijing, China, 100085

Sponsors and Collaborators

Cellonis Biotechnology Co. Ltd.

Investigators


Principal Investigator:	Shi X Y, M.D.	Armed Police General Hospital, P. R. China

More Information


Responsible Party:	Cellonis Biotechnology Co. Ltd., Others
ClinicalTrials.gov Identifier:	NCT01143168 History of Changes
Other Study ID Numbers:	Cellonis-CR-1.3
Study First Received:	June 10, 2010
Last Updated:	June 11, 2010

Keywords provided by Cellonis Biotechnology Co. Ltd.:


stem cells; diabetes mellitus; treatment.

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases	Endocrine System Diseases Autoimmune Diseases Immune System Diseases

ClinicalTrials.gov processed this record on June 28, 2017

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