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

NCT03643614 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-01-27

No results posted yet for this study

Summary

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.

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.

Sponsors & Collaborators

  • South Ural State Medical University

    lead OTHER

Principal Investigators

  • Georgy Dimov, PhD · South Ural State Medical University

  • Viacheslav Vasilyev, PhD · South Ural State Medical University

  • Zhanna Teryushkova, PhD · South Ural State Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-11-15
Completion
2020-01-22

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03643614 on ClinicalTrials.gov