NCT02651233

Brief 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). 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

1 month

First QC Date

January 2, 2016

Last Update Submit

January 7, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index (Calculated in kg/m2)

    Calculated in kg/m2

    1h before the surgery

Secondary Outcomes (2)

  • ADRCs yield (Calculated in number of cells per gram of tissue)

    2h after the surgery

  • ADRCs viability (Calculated in percentage)

    2h after the surgery

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients were healthy individuals, both genders with request for subcutaneous transplantation of autologous cell enriched adipose tissue for different indications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

MeSH Terms

Conditions

SmokingMotor ActivityCoitus

Condition Hierarchy (Ancestors)

BehaviorSexual Behavior

Study Officials

  • Katarina Andjelkov, MD PhD

    BelPrime Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor, principal investigator

Study Record Dates

First Submitted

January 2, 2016

First Posted

January 8, 2016

Study Start

March 1, 2014

Primary Completion

April 1, 2014

Study Completion

April 1, 2015

Last Updated

January 8, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share