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Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts

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ClinicalTrials.gov Identifier: NCT01801878
Recruitment Status : Withdrawn (Difficulty in recruiting research subjects)
First Posted : March 1, 2013
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Brief Summary:
The aim of this study is to evaluate the skin quality of using adipose-drived stromal vascular fraction (SVF) cell taken by automatic centrifuge for adipose-drived cell isolation system into irradiated breasts.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Skin Abnormalities Biological: Adipose SVF cell Biological: Normal saline Not Applicable

Detailed Description:

10 participants who taken conservative mastectomy will be enrolled

  1. Process

    • adipose tissue is obtained from the subject's thigh or abdomen
    • adipose-drived stromal vascular fraction(SVF)cell isolation using automatic centrifuge system
    • adipose-drived stromal vascular fraction(SVF)cell graft into the irradiated breast.
  2. Duration of study

    • entire duration: approximate 30weeks
    • Follow-up period: 12 weeks
    • Enrollment period: 12 weeks
  3. Study design - Randomized, prospective, pilot study

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adipose SVF cell
adipose SVF cell transfer to the half of irradiated breast
Biological: Adipose SVF cell
adipose SVF cell transfer to the half of irradiated breast

Active Comparator: Normal saline
Normal saline inject to the half of irradiated breast
Biological: Normal saline
Normal saline inject to the half of irradiated breast




Primary Outcome Measures :
  1. The change in the breast skin thickness of the pre and post SVF graft from baseline at 12week after procedure [ Time Frame: change in the breast skin thickness from baseline at 12 week ]
    The efficacy is assessed by breast skin thickness measured by radiologist using breast ultrasonography



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female aged between 40 and 60
  • Subjects who diagnosed breast ductal carcinoma in situ of surgical staging T1aN0, negative resection margin of below 2mm in histopathologic examination
  • Subjects who have a relapse-free interval of more than one year after breast-conserving surgery for breast cancer and radiation therapy
  • Subjects who understand the study contents and sign the informed consent

Exclusion Criteria:

  • Subjects who have radiodermatitis
  • Subjects who planned breast reconstruction with autogenous tissue (ex.Transverse Rectus Abdominis Muscle flap)
  • Subjects who have a history of smoking within 3months recently
  • Subjects who participated in other clinical trial within 30 days recently
  • Pregnant or lactating subjects
  • Subjects who have a active infectious disease
  • Subjects who are not eligible for this study at the discretion of the investigator

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): NCT01801878


Locations
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Korea, Republic of
Seoul National Univ. Bundang Hospital
Seongnam-si, Bundang,Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Chanyeong Heo, Ph.D Seoul National University Bundang Hospital
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01801878    
Other Study ID Numbers: B-1206-158-005
06-2012-193 ( Other Identifier: HurimBiocell, Inc )
First Posted: March 1, 2013    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seoul National University Hospital:
breast cancer
loss of elasticity in irradiated breast skin
Other Reconstructive Surgery
Additional relevant MeSH terms:
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Breast Neoplasms
Skin Abnormalities
Congenital Abnormalities
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases