Clinical trial NCT00703599: Safety and Efficacy of Autologous Adipose-Derived Stem Cell Transplantation in Patients With Type 1 Diabetes
Official title: Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Type 1 Diabetes Mellitus
Keywords: Diabetes Mellitus
Adipose-derived stem cells
Adipose stromal vascular fraction
Autologous
Insulin-dependence
Lead sponsor: Adistem Ltd
Sponsor class: INDUSTRY
First posted: 2008-06-23
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
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 stem cells is safe and beneficial in patients with type 1 diabetes.

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 I/II study is to determine whether the intravenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe and efficacious in patients with Type 1 Diabetes Mellitus. Patients will be observed over 12 months following the procedure, with 2 weeks, 1 month and tri-monthly diagnostics and life style questionaires.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of Type I diabetes for at least 2 years
* Insulin-dependent

Exclusion Criteria:

* Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent CVA or acute renal failure.

Primary outcomes:
measure: Lowering of insulin-dependence and anti-hyperglycemic medication dosages
timeFrame: At 2, 4, 12, 24, 36, and 48 weeks
Secondary outcomes:
measure: Lowering of glycosylated hemoglobin (HbA1C).
timeFrame: At 4, 12, 24, 36, and 48 weeks
measure: Increased circulating C-Peptide levels
timeFrame: At 4, 12, 24, 36, and 48 weeks.
measure: Increased general well-being of patients.
timeFrame: At 2, 4, 12, 24, 36, and 48 weeks.
measure: No detrimental change seen in kidney function tests, liver function tests and other haematological parameters.
timeFrame: At 2, 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, Hong Kong
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.