Safety and Efficacy of Autologous Adipose-Derived Stem Cell Transplantation in Patients With Type 1 Diabetes
Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 1 Diabetes
1 other identifier
interventional
30
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2007
Typical duration for phase_1
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
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJuly 1, 2008
June 1, 2008
2 years
June 19, 2008
June 28, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lowering of insulin-dependence and anti-hyperglycemic medication dosages
At 2, 4, 12, 24, 36, and 48 weeks
Secondary Outcomes (4)
Lowering of glycosylated hemoglobin (HbA1C).
At 4, 12, 24, 36, and 48 weeks
Increased circulating C-Peptide levels
At 4, 12, 24, 36, and 48 weeks.
Increased general well-being of patients.
At 2, 4, 12, 24, 36, and 48 weeks.
No detrimental change seen in kidney function tests, liver function tests and other haematological parameters.
At 2, 4, 12, 24, 36, and 48 weeks.
Study Arms (1)
1
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 I diabetes for at least 2 years
- Insulin-dependent
You may not qualify if:
- Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent CVA or acute renal failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Adistem Ltdlead
Study Sites (2)
Beverly Hills Medical Group
Makati City, Manila, 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, Hong Kong
Central Study Contacts
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
November 1, 2009
Study Completion
December 1, 2009
Last Updated
July 1, 2008
Record last verified: 2008-06