Safety and Efficacy of Autologous Adipose-Derived Stem Cell Transplantation in Type 2 Diabetics
Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 2 Diabetes
1 other identifier
interventional
34
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 type-2-diabetes-mellitus
Started Nov 2007
Typical duration for phase_1 type-2-diabetes-mellitus
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 19, 2008
CompletedFirst Posted
Study publicly available on registry
June 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedJuly 1, 2008
June 1, 2008
1.1 years
June 19, 2008
June 28, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lowering of blood glucose be it fasting, random or post prandial
At 2, 4, 12, 24, 36, and 48 weeks
Secondary Outcomes (3)
Decrease in anti-hyperglycemic medication dosages.
At 2, 4, 12, 24, 36, and 48 weeks.
Improvement in the general well-being of patients.
At 2, 4, 12, 24, 36, and 48 weeks.
Lowering of glycosylated hemoglobin (HbA1C).
At 4, 12, 24, 36, and 48 weeks
Study Arms (1)
Treatment Group
EXPERIMENTALThis is the only arm and that is the treatment group.
Interventions
Intravenous administration of autologous activated stromal vascular fraction derived from 100-120 ml lipoaspirate following mini-liposuction of abdominal adipose tissue.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Presence of of previous and/or acute diabetic complications such as myocardial infarction, CVA or nephropathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Adistem Ltdlead
Study Sites (2)
Beverly Hills Medical Group
Makati City, Manila, 1223, Philippines
Veterens Memorial Medical Centre
Quezon City, Manila, 1229, Philippines
Related Publications (1)
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.
PMID: 17495232BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 19, 2008
First Posted
June 23, 2008
Study Start
November 1, 2007
Primary Completion
December 1, 2008
Study Completion
January 1, 2009
Last Updated
July 1, 2008
Record last verified: 2008-06