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

South Ural State Medical University

Status and phase: Completed; Phase 1

Conditions: Rectovaginal Fistula

Treatments: Procedure: Injection of autologous regenerative cells of adipose tissue

Study type: Interventional

Funder types: Other

Identifiers

NCT03643614

RU SUSMU 310855.210617.1

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Female

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

study group

Experimental group

Description:

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

Treatment:

Procedure: Injection of autologous regenerative cells of adipose tissue