Problem of AgingNCT02651233
Factors That Influence Adipose Derived Regenerative Cells' Yield and Viability
An observational study of Problem of Aging and Smoking, run by Clinical Centre of Serbia.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Problem of Aging, Smoking, Physical Activity
- What is being tested?
- ADRCs therapy
- Type of treatment
- Injection or infusion
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients were healthy individuals, both genders with request for subcutaneous transplantation of autologous cell enriched adipose tissue for different indications
Who may be able to join
- 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.
Who cannot join
- The exclusion criteria were autoimmune diseases, inflammatory bowel disease, presence of malignant or chronic infectious disease, or immunosuppressive therapy.
About this study
Official title: 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.
Read the 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.
- Conditions
- Problem of Aging, Smoking, Physical Activity, Gender
- Being tested
- ADRCs therapy
- Medical subject headings
- Smoking, Motor Activity, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADRCs therapyOther
Patients are submitted to manual liposuction and extraction of ADRCS is done with closed system. All patients were candidates for subcutaneous transplantation of autologous cell enriched adipose tissue for different indications.
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (Calculated in kg/m2)
Calculated in kg/m2
Measured: 1h before the surgery
Secondary outcomes (2)
ADRCs yield (Calculated in number of cells per gram of tissue)
Calculated in number of cells per gram of tissue
Measured: 2h after the surgery
ADRCs viability (Calculated in percentage)
Calculated in percentage
Measured: 2h after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startMar 2014
- Primary completionApr 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Problem of AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Centre of Serbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarina Andjelkov, Clinical Centre of Serbia
- Investigators
- Katarina Andjelkov, MD PhD, Principal investigator, BelPrime Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651233
- Sponsor's protocol ID
- CCSerbia
- Status last verified
- Jan 2016
- First submitted
- 2 Jan 2016
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 23800730Mojallal 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.
PubMed 21614659Faustini 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.
PubMed 20486782
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors That May Influence Yield and Viability of Extracted Adipose Derived Regenerative Cells' Per Gram of Fat Tissue
- ClinicalTrials.gov ID
- NCT02651233
- Acronym / sponsor ID
- CCSerbia
- Conditions
- Problem of Aging, Smoking, Physical Activity, Gender
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Clinical Centre of SerbiaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients were healthy individuals, both genders with request for subcutaneous transplantation of autologous cell enriched adipose tissue for different indications
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- The exclusion criteria were autoimmune diseases, inflammatory bowel disease, presence of malignant or chronic infectious disease, or immunosuppressive therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADRCs therapyPatients are submitted to manual liposuction and extraction of ADRCS is done with closed system. All patients were candidates for subcutaneous transplantation of autologous cell enriched adipose tissue for different indications. | Other | – |
Primary outcome
Body Mass Index (Calculated in kg/m2)
Time frame: 1h before the surgery
Calculated in kg/m2
2 secondary outcomes
ADRCs yield (Calculated in number of cells per gram of tissue)
Time frame: 2h after the surgery
ADRCs viability (Calculated in percentage)
Time frame: 2h after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Results publication: PubMed 23800730Buschmann 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.
- Results publication: PubMed 21614659Mojallal 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.
- Results publication: PubMed 20486782Faustini 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.
- Individual participant dataSharing planned: No
Related trials for Problem of Aging
Recruiting
Evaluation of the PPAL
Age Problems
Not yet recruitingObservational study
Vascular Aging and Microcirculation: Physiological Aspects of Vascular Aging in the Elderly Population (VAMP-Aging)
Aging Problems
Active, not recruiting
Brain Health Virtual Reality Study
Aging, Aging Problems
Recruiting
Reducing Blood Pressure in Mid-life Adult Binge Drinkers
Alcohol Drinking, Binge Drinking
Enrolling by invitationObservational study
Swedish Palliative Care Guide (S-PCG) at Nursing Homes
Age Problem, Old Age; Debility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarina Andjelkov, MD PhD principal investigator
BelPrime Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Problem of Aging and Smoking, run by Clinical Centre of Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (Calculated in kg/m2) (time frame: 1h before the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02651233, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.