Autologous Adipose-derived Regenerative Cells Injection for Treatment of Radiation-induced Rectovaginal Fistula

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

August 1, 2017

Primary Completion Date

November 15, 2019

Study Completion Date

January 22, 2020

Conditions
Rectovaginal Fistula
Interventions
PROCEDURE

Injection of autologous regenerative cells of adipose tissue

Autologous regenerative cells of adipose tissue obtained by enzymatic digestion of lipoaspirate are injected diffusively in the submucosal plane of the rectum and vagina with a sharp 27G needle. Adipose tissue that has not been subjected to enzymatic processing is injected through the punctures on the skin into the deep layers of the rectovaginal septum by means of cannula of 1.0-1.2 mm in diameter, 70 mm in length, 0.1-0.2 ml in one retrograde pass of the cannula.

Trial Locations (1)

454092

South Ural State Medical University, Chelyabinsk

All Listed Sponsors
lead

South Ural State Medical University

OTHER

NCT03643614 - Autologous Adipose-derived Regenerative Cells Injection for Treatment of Radiation-induced Rectovaginal Fistula | Biotech Hunter | Biotech Hunter