Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered in Patients With Type II Diabetes
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|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Recruitment Status : Withdrawn (company dissolved)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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|