NCT02923219

Brief Summary

The purpose of this study is to determine whether the adipose-derived stem cells therapy is effective in the treatment of facial rejuvenation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

August 22, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

October 4, 2016

Status Verified

October 1, 2016

Enrollment Period

3 years

First QC Date

August 22, 2016

Last Update Submit

October 2, 2016

Conditions

Facies

Keywords

Facial RejuvenationAdipose-Derived Stem Cells

Outcome Measures

Primary Outcomes (1)

  • The therapeutic evaluation of adipose-derived stem cells or fat cells solely on facial rejuvenation

    With the therapeutic evaluation of adipose-derived stem cells and fat cells solely on facial rejuvenation separately, which can reduce wrinkle and augment collagen of face skin. In order to assess the therapeutic effect, the investigators take face photos/make three-dimensional skin CT of face to evaluate the wrinkle and collagen before the therapy. Then take photos of face/ make three-dimensional skin CT of face to evaluate the wrinkle and collagen/ take patient satisfaction questionnaire and clinician assessment in 1 Months post-surgery. Take photos of face/ make three-dimensional skin CT of face/ take patient satisfaction questionnaire and clinician assessment in 3 Months post-surgery. Then take photos of face/ make three-dimensional skin CT of face to evaluate the wrinkle and collagen/ take patient satisfaction questionnaire and clinician assessment in 6 Months post-surgery. The investigators will summarize the therapeutic effect of facial rejuvenation based on the data.

    1,3 and 6 Months Post-Surgery

Secondary Outcomes (1)

  • The therapeutic evaluation of adipose-derived stem cells combined with fat cells on facial rejuvenation

    1,3 and 6 Months Post-Surgery

Study Arms (1)

Stem cells separation

EXPERIMENTAL

Stem cells separation: The adipose-derived stem cells are separated from vacuumed fat obtained through liposuction of abdomen, hip, thigh and so on. It was confirmed the adipose-derived stem cells can be induced differentiation into fat cells under the special condition in the current literature.Stem cells are used to treat wrinkles and facial rejuvenation.

Biological: Adipose-derived stem cells

Interventions

Adipose-derived stem cellsBIOLOGICAL

The adipose-derived stem cells therapy involve injection of patient's own adipose-derived stem cells. Local anesthetic will be applied to the face prior to the injection. For adipose-derived stem cells preparation, proper volume of fat cells will be collected from each patient just before each procedure. The stem cells will be injected into each standardized injection point in a superficial manner. The injections points are along the inferior border of cheek and mid-cheek and temple, where will be followed by 10-15 minutes of icing.

Stem cells separation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females
  • Ages18-60
  • Patients of all racial and ethnic origins
  • Patients of all undergoing facial rejuvenation

You may not qualify if:

  • Ages under 18, and above 60
  • Female patients in pregnancy or menstrual period
  • Patients undergoing facial rejuvenation using other methods including botox injections, chemical peels, face lifts and others
  • Patients using blood thinners, aspirin and hormone, that cannot be stopped
  • Patients suffering with severe organic disease, such as coronary heart disease, hypertension, diabetes, lung dysfunction and so on
  • Patients suffering with mental disease, and acute or chronic infectious diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Hetherington HE, Block JE. Facial fat grafting with a prototype injection control device. Clin Cosmet Investig Dermatol. 2013 Sep 13;6:201-9. doi: 10.2147/CCID.S47469. eCollection 2013.

    PMID: 24049453BACKGROUND

  • Winters R, Moulthrop T. Is autologous fat grafting superior to other fillers for facial rejuvenation? Laryngoscope. 2013 May;123(5):1068-9. doi: 10.1002/lary.23614. No abstract available.

    PMID: 23619619BACKGROUND

  • Zuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP, Hedrick MH. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001 Apr;7(2):211-28. doi: 10.1089/107632701300062859.

    PMID: 11304456BACKGROUND

  • Yilgor Huri P, Cook CA, Hutton DL, Goh BC, Gimble JM, DiGirolamo DJ, Grayson WL. Biophysical cues enhance myogenesis of human adipose derived stem/stromal cells. Biochem Biophys Res Commun. 2013 Aug 16;438(1):180-5. doi: 10.1016/j.bbrc.2013.07.049. Epub 2013 Jul 20.

    PMID: 23876311BACKGROUND

  • Shi Z, Neoh KG, Kang ET, Poh CK, Wang W. Enhanced endothelial differentiation of adipose-derived stem cells by substrate nanotopography. J Tissue Eng Regen Med. 2014 Jan;8(1):50-8. doi: 10.1002/term.1496. Epub 2012 May 24.

    PMID: 22628362BACKGROUND

  • Salgado AJ, Reis RL, Sousa NJ, Gimble JM. Adipose tissue derived stem cells secretome: soluble factors and their roles in regenerative medicine. Curr Stem Cell Res Ther. 2010 Jun;5(2):103-10. doi: 10.2174/157488810791268564.

    PMID: 19941460BACKGROUND

  • Li Q, Zhang A, Tao C, Li X, Jin P. The role of SDF-1-CXCR4/CXCR7 axis in biological behaviors of adipose tissue-derived mesenchymal stem cells in vitro. Biochem Biophys Res Commun. 2013 Nov 22;441(3):675-80. doi: 10.1016/j.bbrc.2013.10.071. Epub 2013 Oct 30.

    PMID: 24184476BACKGROUND

  • Yin Y, Li J, Li Q, Zhang A, Jin P. Autologous fat graft assisted by stromal vascular fraction improves facial skin quality: A randomized controlled trial. J Plast Reconstr Aesthet Surg. 2020 Jun;73(6):1166-1173. doi: 10.1016/j.bjps.2019.11.010. Epub 2019 Nov 29.

    PMID: 32269011DERIVED

MeSH Terms

Conditions

Facies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jin Peisheng

    the Affiliated Hospital of the XuZhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Peisheng

CONTACT

+860516-85802212jinps2006@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-President of the Affiliated Hospital of Xuzhou Medical College

Study Record Dates

First Submitted

August 22, 2016

First Posted

October 4, 2016

Study Start

January 1, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

October 4, 2016

Record last verified: 2016-10