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FaciesADSCsNCT02923219

The Clinical Application of Adipose-Derived Stem Cells on Facial Rejuvenation

A study testing Adipose-derived stem cells in people with Facies, run by Xuzhou Medical University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Facies
What is being tested?
Adipose-derived stem cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
Jan 2017to Jan 2020
Phase
Interventional
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 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Jin Peisheng contact

+860516-85802212

jinps2006@163.com

About this study

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

Read the detailed description

This study will be a prospective study of patients who undergo adipose-derived stem cells therapy for facial rejuvenation at the hospital of Xuzhou medical university. The therapy involves injection of patient's own adipose-derived stem cells, which 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, osteoblasts, chondrocytes, muscle cells, endothelial cells and so on under the corresponding condition in the current literature. The therapy has evolved as a less invasive technique for facial rejuvenation compared to more traditional techniques，such as fat cells injection, sodium hyaluronate injection. Through the use of pre and post treatment photos, three-dimensional skin CT, in addition to the therapeutic evaluation, patient satisfaction questionnaire and a clinician assessment, it is our hope that the investigators will confirm the rejuvenating capabilities of adipose-derived stem cells therapy.

Conditions
Facies
Being tested
Adipose-derived stem cells
Keywords
Facial Rejuvenation, Adipose-Derived Stem Cells
Medical subject headings
Facies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02923219
Study groupRoleWhat they receive
Stem cells separationExperimentalStem 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.
Receives: Biological: Adipose-derived stem cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1,3 and 6 Months Post-Surgery

Secondary outcomes (1)

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

    With the therapeutic evaluation of adipose-derived stem cells combined with fat cells on facial rejuvenation.The investigators take photos of face before the therapy and in 1, 3 and 6 Months Post-Surgery, take three-dimensional skin CT of face to evaluate the wrinkle and collagen and so on at the time points of pre-surgery and in 1, 3 and 6 Months post-surgery. In addition to the therapeutic evaluation, take patient satisfaction questionnaire and clinician assessment in 1, 3 and 6 Months post-surgery. The multiple measurements will be aggregated to arrive at facial rejuvenation. Compare the secondary outcome with primary outcome, then it can summarize the best method of facial rejuvenation.

    Measured: 1,3 and 6 Months Post-Surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionJan 2020 (estimated)
  4. Study completionJan 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02923219
Sponsor's protocol ID
XYFY2016-KL020-01
Acronym
ADSCs
Status last verified
Oct 2016
First submitted
22 Aug 2016
Last updated
4 Oct 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 24049453

  • 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.

    PubMed 23619619

  • 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.

    PubMed 11304456

  • 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.

    PubMed 23876311

  • 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.

    PubMed 22628362

  • 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.

    PubMed 19941460

  • 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.

    PubMed 24184476

  • 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.

    PubMed 32269011

Questions about this trial

What is this clinical trial studying?

A study testing Adipose-derived stem cells in people with Facies, run by Xuzhou Medical University.

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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Oct 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jin Peisheng (+860516-85802212, jinps2006@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The therapeutic evaluation of adipose-derived stem cells or fat cells solely on facial rejuvenation (time frame: 1,3 and 6 Months Post-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 NCT02923219, which also lists 8 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 4 Oct 2016.

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