Small Intestinal Submucosa Scaffold Combined With Adipose-derived Stem Cells to Form an Adipocyte-containing Hypodermis

NCT ID: NCT02560350

Last Updated: 2015-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-08-31

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.

Detailed Description

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. All protocols using human samples were approval by the Institutional Review Board of Nanfang Hospital (no.18502), and samples were obtained with written informed consent. Ten millilitres of discarded adipose tissue from the humans was washed extensively with equal volumes of phosphate-buffered saline (PBS); minced into a fine, homogeneous preparation; and digested at 37°C for 30 min with 0.125% type I collagenase. Enzyme activity was neutralized with Dulbecco's modified Eagle's medium (DMEM) containing 10% FBS. Then, the sample was filtered through a 200-mm nylon mesh to remove cellular debris and was centrifuged at 1500 revolutions per minute (rpm) for 5 min. The precipitate was resuspended in 6~10 ml NH4Cl and incubated at room temperature for 10 min to lyse contaminating red blood cells. The compound was centrifuged at 1500 rpm for an additional 5 min. The ASCs were collected via centrifugation as described above, resuspended in 2 ml of control medium (DMEM containing 10% FBS and 1% antibiotic/antimycotic solution) and incubated at 37°C in a humidified chamber containing 5% CO2 for 48 h. Next, the plates were washed extensively with PBS to remove residual non-adherent red blood cells and debris. The resulting cell population was termed ASCs, and the cultures were expanded with media changes at 3-day intervals. Cells at passage 1 through 6 were used for all experiments.

Conditions

Adipogenesis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

no intervention

no intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• sick people

• Minimum Eligible Age: 28 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ping Jiang, PhD

Role: STUDY_DIRECTOR

Nanfang Hospital, Southern Medical University

Locations

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ping Jiang, PhD

Role: CONTACT

jp9585@163.com

13729865869

Facility Contacts

Weifeng Huang, MD

Role: primary

huangwf8@hotmail.com

8613729865869

Other Identifiers

NFEC-2015-090

Identifier Type: -

Identifier Source: org_study_id