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

NCT03643614 | Completed Phase 1

• 1 other identifier: RU SUSMU 310855.210617.1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

adipose derived stromal cells; stromal vascular fraction; mesenchymal stem cells; rectovaginal fistula

Outcome Measures

Primary Outcomes (2)

• Serious adverse events

  Frequency, type and severity of serious adverse events (SAE)

  4 weeks after injection of adipose-derived regenerative cells

• Serious adverse reactions

  Frequency, type and severity of serious adverse reactions (SAR)

  4 weeks after injection of adipose-derived regenerative cells

Secondary Outcomes (4)

• Changes of fistula size

  48 weeks after intervention

• Changes in rectovaginal soft tissue density and flexibility

  48 weeks after intervention

• Quality of life monitoring - 1

  48 weeks after intervention

• Quality of life monitoring - 2

  48 weeks after intervention

Study Arms (1)

study group

EXPERIMENTAL

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

Procedure: Injection of autologous regenerative cells of adipose tissue

Interventions

Injection of autologous regenerative cells of adipose tissue 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.

study group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• South Ural State Medical University: lead

Study Sites (1)

South Ural State Medical University

Chelyabinsk, Chelyabinsk Oblast, 454092, Russia

Location

MeSH Terms

Conditions

Rectovaginal Fistula

Condition Hierarchy (Ancestors)

Rectal Fistula; Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Vaginal Fistula; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Georgy Dimov, PhD

  South Ural State Medical University

  STUDY CHAIR

• Viacheslav Vasilyev, PhD

  South Ural State Medical University

  STUDY DIRECTOR

• Zhanna Teryushkova, PhD

  South Ural State Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 23, 2018
• Study Start: August 1, 2017
• Primary Completion: November 15, 2019
• Study Completion: January 22, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

RU (1)