Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered in Patients With Type II Diabetes
|ClinicalTrials.gov Identifier: NCT01453751|
Recruitment Status : Withdrawn (company dissolved)
First Posted : October 18, 2011
Last Update Posted : November 24, 2017
This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stromal vascular fraction cells implantation via intravenous infusion.
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed Type II Diabetes Mellitus.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Type II||Procedure: Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intravenously in Patients With Type II Diabetes|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Intravenous Injection of AD-SVF
Intravenous administration of AD-SVF.
Procedure: Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF)
ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.
- Reduction of insulin requirement by > 50% [ Time Frame: 3 months and 6 months ]
- Number of adverse events reported [ Time Frame: up to the 6-month period following treatment ]The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.
- Improvement of Hemoglobin A1c(HbA1c) levels as compared to baseline [ Time Frame: 3 months and 6 months ]Blood sample
- reduction in requirement of insulin dosage compared to baseline [ Time Frame: 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01453751
|United States, Florida|
|Ageless Regenerative Institute LLC|
|Aventura, Florida, United States, 33180|
|Principal Investigator:||Sharon McQuillan, MD||Ageless Regenerative Institute|