Clinical trial NCT00703612: Safety and Efficacy of Autologous Adipose-Derived Stem Cell Transplantation in Type 2 Diabetics
Official title: Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus
Adipose-derived stem cells
Adipose stromal vascular fraction
Autologous
Hyperglycemia
Lead sponsor: Adistem Ltd
Sponsor class: INDUSTRY
First posted: 2008-06-23
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Lowering of blood glucose be it fasting, random or post prandial
timeFrame: At 2, 4, 12, 24, 36, and 48 weeks
Secondary outcomes:
measure: Decrease in anti-hyperglycemic medication dosages.
timeFrame: At 2, 4, 12, 24, 36, and 48 weeks.
measure: Improvement in the general well-being of patients.
timeFrame: At 2, 4, 12, 24, 36, and 48 weeks.
measure: Lowering of glycosylated hemoglobin (HbA1C).
timeFrame: At 4, 12, 24, 36, and 48 weeks
Other outcomes:
Locations:
city: Makati City
country: Philippines
facility: Beverly Hills Medical Group
state: Manila
city: Quezon City
country: Philippines
facility: Veterens Memorial Medical Centre
state: Manila
Study officials:
affiliation: Veterens Memorial Medical Centre, Philippines
name: Emeritta A Barrenechea, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Philippines, College of Medicine.
name: Florencio Q Lucero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Far Eastern University-NRMF Hospital, Quezon City, Philippines
name: Letitia Lucero-Palma, MD
role: STUDY_DIRECTOR
affiliation: Adistem Ltd
name: Bill Paspaliaris, PhD
role: STUDY_CHAIR
References:
citation: Gimble JM, Katz AJ, Bunnell BA. Adipose-derived stem cells for regenerative medicine. Circ Res. 2007 May 11;100(9):1249-60. doi: 10.1161/01.RES.0000265074.83288.09.