- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02651233
Factors That Influence Adipose Derived Regenerative Cells' Yield and Viability
Factors That May Influence Yield and Viability of Extracted Adipose Derived Regenerative Cells' Per Gram of Fat Tissue
Human adipose tissue has been shown to contain a group of cells that possess extensive proliferative capacity and the ability to differentiate into multiple cell lineages. Cells isolated from the fatty portion are termed processed lipoaspirate cells that contain adipose-derived regenerative cells (ADRCs). ADRCs are most conveniently extracted from tissue during an elective cosmetic liposuction procedure but may also be obtained from resected adipose tissue.
This study is aimed to verify if there are differences between the number and viability of cells obtained from patients with different age, sex, Body Mass Index (BMI), smoking and physical activity, within the different amount of processed fat.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Method: We analyzed 46 patients, both sexes, who filled out a questionnaire about their age and habits (sport activity and smoking). They were then divided into two groups. Group 1 consisted of patients with normal BMI range from 18,5 to 24.9 (n=27) and Group 2 had overweight patients with BMI index 25 to 29.9 (n=19). There were no underweight or obese patients. All 46 patients had the ADRCS extracted for therapeutical use, but with different indications. The mixture of 180 mL saline solution, 1mL Epinephrine (1:10,000) and 20 mL of 2% lidocaine is injected in the subcutaneous layer of the abdominal wall to allow the tumescence and to decrease the blood loss. The manual liposuction procedure has been carried out through two or three small incisions using harvester (Tulip® medical products, San Diego, USA). All of them had liposuction done by the author and in the same manner (tumescent technique, same cannula) to obtain 120-200ml of fat. The harvest site is then covered with a pressure dressing for 10 days to reduce swelling and hematoma. The closed system PureGraft® 250mL (PureGraft®, Solana Beach, California, USA) has been used used to collect the specimen. The specimen is transferred within 15 min to the BelPrime Clinic laboratory where the Celution® 800/CRS system (Cytori Therapeutics, Inc. San Diego, California, USA) is applied to process the lipoaspirate in order to obtain ADRCs. The Celution® 800/CRS system is a closed automated medical device that helps to separate blood and fat. The system will then digests fat using the proprietary enzyme reagent Celase 835/CRS (Cytori Therapeutics, Inc. San Diego, California, USA) to release the stromal vascular fraction (SVF). SVF is subsequently concentrated by a short centrifugation and then automated wash cycles to obtain the ADRC fraction. This 90 to 120-minute process provides approximately 5mL of pellet. A few drops of the obtained pellet were immediately used for cell counting (ChemoMetec A/S DK-3450, Allerod, Denmark).
Results/Complications: Number of ADRCS obtained, cells' viability, viable ADRCS per gram of fat processed, ADRCS for active dose and total volume for cell therapy were statistically analyzed in correlation with patients' BMI, sport activity, sex, age and smoking habits and amount of processed fat.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
The inclusion criteria were: healthy individuals, both genders, there were no age nor BMI restriction, smokers and no smokers searching for local, subcutaneous transplantation of ADRCs.
Exclusion Criteria:
The exclusion criteria were autoimmune diseases, inflammatory bowel disease, presence of malignant or chronic infectious disease, or immunosuppressive therapy.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index (Calculated in kg/m2)
Time Frame: 1h before the surgery
|
Calculated in kg/m2
|
1h before the surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ADRCs yield (Calculated in number of cells per gram of tissue)
Time Frame: 2h after the surgery
|
Calculated in number of cells per gram of tissue
|
2h after the surgery
|
ADRCs viability (Calculated in percentage)
Time Frame: 2h after the surgery
|
Calculated in percentage
|
2h after the surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Katarina Andjelkov, MD PhD, BelPrime Clinic
Publications and helpful links
General Publications
- Buschmann J, Gao S, Harter L, Hemmi S, Welti M, Werner CM, Calcagni M, Cinelli P, Wanner GA. Yield and proliferation rate of adipose-derived stromal cells as a function of age, body mass index and harvest site-increasing the yield by use of adherent and supernatant fractions? Cytotherapy. 2013 Sep;15(9):1098-105. doi: 10.1016/j.jcyt.2013.04.009. Epub 2013 Jun 22.
- Mojallal A, Lequeux C, Shipkov C, Duclos A, Braye F, Rohrich R, Brown S, Damour O. Influence of age and body mass index on the yield and proliferation capacity of adipose-derived stem cells. Aesthetic Plast Surg. 2011 Dec;35(6):1097-105. doi: 10.1007/s00266-011-9743-7. Epub 2011 May 26.
- Faustini M, Bucco M, Chlapanidas T, Lucconi G, Marazzi M, Tosca MC, Gaetani P, Klinger M, Villani S, Ferretti VV, Vigo D, Torre ML. Nonexpanded mesenchymal stem cells for regenerative medicine: yield in stromal vascular fraction from adipose tissues. Tissue Eng Part C Methods. 2010 Dec;16(6):1515-21. doi: 10.1089/ten.TEC.2010.0214. Epub 2010 Sep 6.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CCSerbia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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