Autologous Prefabrication of Body Surface Tissues/ Organs(e.g. Joint)

Soft Tissue Infections Clinical Trial

Official title:

Phase 1/2 Study of Autologous Tissues/Body Surface Organs Prefabrication in Tissue Reconstruction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02595047
• Other study ID #: [2012]23
• Status: Active, not recruiting
• Phase: N/A
• First received: September 27, 2015
• Last updated: October 30, 2015
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: October 2015
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to observe the feasibility and its application of autologous prefabrication for body surface tissues/oranges

Description:

In the field of tissue regeneration techniques, the in vitro processes and other exogenous factors still have many uncertainties. These uncertainties have hampered road to the clinical application. As the importance of in vivo environment has aroused more awareness, the investigators validated the hypothesis that the feasibility of self-regeneration prefabricated unaided by any in vitro culture process or exogenous elements.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: December 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 65 Years

Eligibility

Inclusion Criteria:

• With body surface tissue or organ defects (e.g., ear, nose, bone and joint) requiring reconstruction.

Exclusion Criteria:

• evidence of infection, ischemia, ulcer or other pathological changes within the prefabricated area which defined as not suitable for tissues regeneration

• history of delayed healing, radiational therapy;

• significant renal, cardiovascular, hepatic and psychiatric diseases;

• significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV);

• BMI >30;

• history of any hematological disease, including leukopenia, thrombocytopenia, or thrombocytosis;

• Evidence of malignant diseases

• unwillingness to participate.

Study Design

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

Related Conditions & MeSH terms

• Intentional Self Harm by Other Specified Means
• Soft Tissue Infections

Intervention

Procedure:
• tissue/ organ prefabrication
tissue/ organ is prefabricated in vivo independent of exogenous factors for replacement/ reconstruction purposes

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	survival of prefabricated tissue after grafting	Assessed by radiologic imaging (CT, MRT)	3, 6, 12, and 36 months after grafting	Yes
Other	biomechanical function of prefabricated tissue after grafting	Assessed by total range of motion (degree)	3, 6, 12, and 36 months after grafting	Yes
Other	biomechanical function of prefabricated tissue after grafting	Assessed by grip strength (kg)	3, 6, 12, and 36 months after grafting	Yes
Primary	Occurence of major adverse events	Including infection, necrosis, resorption	through study completion 12 months after prefabrication	Yes
Secondary	Feasibility of self-prefabrication	To observe the regeneration changes of prefabricated neo-tissue by histology (staining) and biomechanical analysis (bone density, Young`s modulus)	3, 6, and 12 months after prefabrication	Yes