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Trial record 3 of 6874 for:    stem cells

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

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ClinicalTrials.gov Identifier: NCT02923219
Recruitment Status : Not yet recruiting
First Posted : October 4, 2016
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
Jin Peisheng, Xuzhou Medical University

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.

Condition or disease Intervention/treatment Phase
Facies Biological: Adipose-derived stem cells Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Clinical Application of Adipose-Derived Stem Cells on Facial Rejuvenation
Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: Stem cells separation
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
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.




Primary Outcome Measures :
  1. The therapeutic evaluation of adipose-derived stem cells or fat cells solely on facial rejuvenation [ Time Frame: 1,3 and 6 Months Post-Surgery ]
    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.


Secondary Outcome Measures :
  1. The therapeutic evaluation of adipose-derived stem cells combined with fat cells on facial rejuvenation [ Time Frame: 1,3 and 6 Months Post-Surgery ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923219


Contacts
Contact: Jin Peisheng +860516-85802212 jinps2006@163.com

Sponsors and Collaborators
Xuzhou Medical University
Investigators
Principal Investigator: Jin Peisheng the Affiliated Hospital of the XuZhou Medical University

Publications:

Responsible Party: Jin Peisheng, Vice-President of the Affiliated Hospital of Xuzhou Medical College, Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT02923219     History of Changes
Other Study ID Numbers: XYFY2016-KL020-01
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jin Peisheng, Xuzhou Medical University:
Facial Rejuvenation
Adipose-Derived Stem Cells