Overview

This trial is active, not recruiting.

Conditions soft tissue infections, intentional self harm by other specified means
Treatment tissue/ organ prefabrication
Sponsor Shanghai Jiao Tong University School of Medicine
Start date January 2013
End date June 2015
Trial size 1 participant
Trial identifier NCT02595047, [2012]23

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
in vivo generation of autologous tissue for joint replacement
tissue/ organ prefabrication ear, joint, bone, cartilage
tissue/ organ is prefabricated in vivo independent of exogenous factors for replacement/ reconstruction purposes

Primary Outcomes

Measure
Occurence of major adverse events
time frame: through study completion 12 months after prefabrication

Secondary Outcomes

Measure
Feasibility of self-prefabrication
time frame: 3, 6, and 12 months after prefabrication

Eligibility Criteria

Male or female participants from 5 years up to 65 years old.

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.

Additional Information

Official title Phase 1/2 Study of Autologous Tissues/Body Surface Organs Prefabrication in Tissue Reconstruction
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Shanghai Jiao Tong University School of Medicine.