Rectovaginal Fistula Clinical Trial
Official title:
Evaluation of Effectiveness and Safety of Autologous Adipose-derived Regenerative Cells Injection for Treatment of Radiation-induced Rectovaginal Fistula
A new strategy for treatment of late radiation damage is to develop methods aimed at
stimulating the regenerative capabilities of irradiated tissues. Since the main pathogenetic
mechanism of the development of late radiation damage is the death or damage of the
replicative mechanism of stromal cells (SC), a justified approach can be considered as
transplantation of intact SC. Currently, there is convincing evidence in the scientific
literature that the injection of intact autologous SCs into the zone of fibrosis surrounding
the chronic radiation ulcer leads to the healing of a wound defect.
An Initiative Clinical Trial. Introduction of autologous regenerative cells of adipose tissue
for the treatment of post-irradiation vaginal-rectal fistula. It is assumed that patients
will be included in the project within 12 months; the monitoring of each patient will last
for 6 months; the total duration of the clinical part of the study will be 18 months; The
total duration of the clinical trial including the preparatory phase and the writing of the
report is about 24 months. It is assumed that at least 16 patients aged 20 to 75 years who
have verified diagnosis of post-irradiation vaginal-rectal fistula will participate in this
pilot project. The aims of the clinical trial are to preliminarily assess the safety,
effectiveness and quality of life of patients after introducing autologous regenerative cells
of adipose tissue for the treatment of post-irradiation vaginal-rectal fistula.
n/a
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