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

Facies Clinical Trial

— ADSCs  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02923219
• Other study ID #: XYFY2016-KL020-01
• Status: Not yet recruiting
• Phase: N/A
• First received: August 22, 2016
• Last updated: October 2, 2016
• Start date: January 2017
• Est. completion date: January 2020

Study information

• Verified date: October 2016
• Source: Xuzhou Medical University
• Contact: Jin Peisheng
• Phone: +860516-85802212
• Email: jinps2006[@]163.com
• Is FDA regulated: No
• Health authority: China: Jiangsu Provincial Commission of Health and Family Planning
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Males and females

• Ages18-60

• Patients of all racial and ethnic origins

• Patients of all undergoing facial rejuvenation

Exclusion Criteria:

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Facies

Intervention

Biological:
• Adipose-derived stem cells
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Medical University

References & Publications (7)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	1,3 and 6 Months Post-Surgery	No