Safety and Efficacy of Autologous Adipose-Derived Stem Cell Transplantation in Type 2 Diabetics - Full Text View

Sponsored by:	Adistem Ltd
Information provided by:	Adistem Ltd
ClinicalTrials.gov Identifier:	NCT00703612

Purpose

The purpose of this study is to determine whether intravenous administration of autologous adipose-derived stem cells is of benefit in the management of types 2 diabetics.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Procedure: Autologous Adipose-derived Stem cells	Phase I Phase II

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 2 Diabetes

Further study details as provided by Adistem Ltd:

Primary Outcome Measures:

Lowering of blood glucose be it fasting, random or post prandial [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Decrease in anti-hyperglycemic medication dosages. [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks. ] [ Designated as safety issue: Yes ]
Improvement in the general well-being of patients. [ Time Frame: At 2, 4, 12, 24, 36, and 48 weeks. ] [ Designated as safety issue: Yes ]
Lowering of glycosylated hemoglobin (HbA1C). [ Time Frame: At 4, 12, 24, 36, and 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	34
Study Start Date:	November 2007
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment Group: Experimental This is the only arm and that is the treatment group.	Procedure: Autologous Adipose-derived Stem cells Intravenous administration of autologous activated stromal vascular fraction derived from 100-120 ml lipoaspirate following mini-liposuction of abdominal adipose tissue.

Detailed Description:

Diabetes Mellitus is of large epidemic proportions worldwide. It is proliferating at such a fast rate that new novel drugs and other therapeutic approaches are required. The purpose of this Phase 1/Phase 2 study is to determine whether the intavenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe to and can benefit the disease pathology of patients with Type 2 Diabetes Mellitus (insulin resistance). Patients will be observed over 12 months following the procedure, with a 2 week, 1 month and then tri monthly diagnostics and life style questionaires.

Eligibility

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed diagnosis of Type II diabetes for at least 2 years
Type 2 diabetics on oral hypoglycemic agents and/or insulin
Fasting blood sugar of >200mg% on at least two occasions
Willing to keep a weekly diary and undergo observation for 12 months

Exclusion Criteria:

Presence of of previous and/or acute diabetic complications such as myocardial infarction, CVA or nephropathy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703612

Locations

Philippines, Manila
Beverly Hills Medical Group
Makati City, Manila, Philippines, 1223
Veterens Memorial Medical Centre
Quezon City, Manila, Philippines, 1229

Sponsors and Collaborators

Adistem Ltd

Investigators

Principal Investigator:	Emeritta A Barrenechea, MD	Veterens Memorial Medical Centre, Philippines
Principal Investigator:	Florencio Q Lucero, MD	University of Philippines, College of Medicine.
Study Director:	Letitia Lucero-Palma, MD	Far Eastern University-NRMF Hospital, Quezon City, Philippines
Study Chair:	Bill Paspaliaris, PhD	Adistem Ltd

More Information

NIH website describing basic facts on adult stem cells This link exits the ClinicalTrials.gov site

Publications:

Gimble JM, Katz AJ, Bunnell BA. Adipose-derived stem cells for regenerative medicine. Circ Res. 2007 May 11;100(9):1249-60. Review.

Responsible Party:	Adistem Ltd ( Bill Paspaliaris / Director )
Study ID Numbers:	Adis-002
Study First Received:	June 19, 2008
Last Updated:	June 28, 2008
ClinicalTrials.gov Identifier:	NCT00703612
Health Authority:	Philippines: Department of Health

Keywords provided by Adistem Ltd:

Diabetes Mellitus
Adipose-derived stem cells
Adipose stromal vascular fraction
Autologous
Hyperglycemia

Study placed in the following topic categories:

Metabolic Diseases
Hyperglycemia
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 15, 2009