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

NCT ID: NCT03643614

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2020-01-22

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study group

Injection of autologous regenerative cells of adipose tissue for treatment of radiation induced rectovaginal fistulas

Group Type: EXPERIMENTAL

Injection of autologous regenerative cells of adipose tissue

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of radiation-induced rectovaginal fistula established at least six months after radiation therapy
• Absence of oncological disease relapse during whole observation period
• Absence of rectal and anal cancer
• Patient have read and signed informed consent

Exclusion Criteria

• Contraindications for local/general anesthesia or a history of anesthetic medicines allergy
• Acute hemorrhoid or anal fissure
• Acute purulent paraproctitis
• Inflammatory colon diseases
• History of extensive posttraumatic or postoperative alterations which causes obstacles to follow protocol examination
• Chronic sub- or decompensated internal organs diseases
• Clinically significant laboratory tests abnormalities
• Conditions that limits patient compliance (dementia, psycho-neurological diseases, drug abuse, alcohol abuse etc.)
• Patients involved in other clinical trials or taking medications under research during last three months
• Cancer patients including postoperative chemo- or/and radiotherapy at least three months after surgery
• Patients with increased activated partial thromboplastin time level 1,8 times above normal
• Patients who take anticoagulants or took anticoagulants at least one month before including into trial
• Patients who take or took before investigation glycoprotein inhibitors IIB/IIIA
• Patients with history of taking medications that influence fatty tissue structure

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

South Ural State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Georgy Dimov, PhD

Role: STUDY_CHAIR

South Ural State Medical University

Viacheslav Vasilyev, PhD

Role: STUDY_DIRECTOR

South Ural State Medical University

Zhanna Teryushkova, PhD

Role: PRINCIPAL_INVESTIGATOR

South Ural State Medical University

Locations

South Ural State Medical University

Chelyabinsk, Chelyabinsk Oblast, Russia

Countries

Russia

Other Identifiers

RU SUSMU 310855.210617.1

Identifier Type: -

Identifier Source: org_study_id