Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease
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|ClinicalTrials.gov Identifier: NCT01559051|
Recruitment Status : Withdrawn (company dissolved)
First Posted : March 21, 2012
Last Update Posted : November 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Procedure: Lipoaspiration with Local anesthesia||Phase 1 Phase 2|
This will be an open-label, non-randomized multi-center patient sponsored study of Autologous SVF (AD-SVF) implantation after liposuction using an IV delivery system and Inhalation infusion. AD-SVF 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. The cells will be delivered intravenously.
The adipose tissue specimen will be collected from the patient's abdomen or applicable area using tumescent syringe liposuction. The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred for IV delivery. The number of cells injected will vary depending on the amount of tissue processed and the number of cells obtained from the process.
|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 Intra-venous and Inhalation Implantation of Autologous Adipose-Derived Stromal Vascular Fraction Cells in Patients With Chronic Obstructive Pulmonary Disease|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Intravenous Injection and Inhalation infusion of AD-SVF
AD-SVF harvested from Autologous Adipose Tissue will be deliver after processing via IV and Inhalation
Procedure: Lipoaspiration with Local anesthesia
Patients undergo a liposuction under local Anethesia. The AD-SVF are then isolated and infused IV and by inhalation delivery.
Other Name: Liposuction
- Functional Capacity improved compared to baseline [ Time Frame: 3 months, 6 months ]6 Minute Walk Test
- Number of adverse events [ Time Frame: 3 months, 6 months ]
- Quality of Life improved compared to baseline [ Time Frame: 3 months, 6 months ]St. George Respiratory Questionnaire
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): NCT01559051
|United States, Florida|
|Ageless Regenerative Institute LLC|
|Aventura, Florida, United States, 33180|
|Principal Investigator:||Sharon McQuillan, MD||Ageless Regenerative Institute|