NCT02560350

Brief Summary

Human adipose tissues were obtained from five healthy adult women who underwent abdominal liposuction. They were aged 28 to 45 years (mean, 32.15±4.8 years) and had no infectious or endocrine diseases. Ten millilitres of discarded adipose tissue from the humans was used to gain the adipose-derived stem cells. In this study, the investigators will evaluate the potential of a small intestinal submucosa scaffold combined with adipose-derived stem cells to form an adipocyte-containing hypodermis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

September 1, 2015

Last Update Submit

September 24, 2015

Conditions

Adipogenesis

Keywords

adipose-derived stem cellssmall intestinal submucosaadipocyte-containing hypodermis

Outcome Measures

Primary Outcomes (1)

  • The adipogenesis of adipose-derived stem cells combined with the small intestinal submucosa by histological observation

    From 2015-9 to 2016-9

    up to 12 months

Secondary Outcomes (2)

  • The proliferation of adipose-derived stem cells after seeding on the SIS scaffold by MTT method

    up to 12 months

  • The adhesion of adipose-derived stem cells after seeding on the SIS scaffold by histological observation

    up to 12 months

Interventions

no interventionOTHER

no intervention

Eligibility Criteria

Age28 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

healthy people with normal adipose tissue

You may qualify if:

  • healthy people with no infectious diseases
  • healthy people with no endocrine diseases

You may not qualify if:

  • sick people

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Study Officials

  • Ping Jiang, PhD

    Nanfang Hospital, Southern Medical University

    STUDY DIRECTOR

Central Study Contacts

Ping Jiang, PhD

CONTACT

13729865869jp9585@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2015

First Posted

September 25, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 25, 2015

Record last verified: 2015-09

Locations

CN(1)