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

Primary Purpose

Rectovaginal Fistula

Status

Completed

Phase

Phase 1

Locations

Russian Federation

Study Type

Interventional

Intervention

Injection of autologous regenerative cells of adipose tissue

About this trial

This is an interventional treatment trial for Rectovaginal Fistula focused on measuring adipose derived stromal cells, stromal vascular fraction, mesenchymal stem cells, rectovaginal fistula

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

South Ural State Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

study group

Arm Description

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

Outcomes

Primary Outcome Measures

Serious adverse events

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

Serious adverse reactions

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

Secondary Outcome Measures

Changes of fistula size

Intervention impact on dimensions of rectovaginal fistula

Changes in rectovaginal soft tissue density and flexibility

Intervention impact on soft tissue density and flexibility assessed by ultrasound elastography

Quality of life monitoring - 1

Quality of life estimated by validated questionnaire: The Short Form (36) Health Survey (SF-36). SF-36 is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health

Quality of life monitoring - 2

Quality of life estimated by validated questionnaire. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30 with module for proctitis-23 is a questionnaire developed to assess the proctitis-specific quality of life of cancer patients. Each subscale values varies from 1 to 4. Lower values represents better life quality. Total score is computed by summarizing of subscales.

Full Information

NCT ID

NCT03643614

First Posted

August 21, 2018

Last Updated

January 23, 2020

Sponsor

South Ural State Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03643614

Brief Title

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

Official Title

Evaluation of Effectiveness and Safety of Autologous Adipose-derived Regenerative Cells Injection for Treatment of Radiation-induced Rectovaginal Fistula

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

November 15, 2019 (Actual)

Study Completion Date

January 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

South Ural State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectovaginal Fistula

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

study group

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Injection of autologous regenerative cells of adipose tissue

Intervention Description

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.

Primary Outcome Measure Information:

Title

Serious adverse events

Description

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

Time Frame

4 weeks after injection of adipose-derived regenerative cells

Title

Serious adverse reactions

Description

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

Time Frame

4 weeks after injection of adipose-derived regenerative cells

Secondary Outcome Measure Information:

Title

Changes of fistula size

Description

Intervention impact on dimensions of rectovaginal fistula

Time Frame

48 weeks after intervention

Title

Changes in rectovaginal soft tissue density and flexibility

Description

Intervention impact on soft tissue density and flexibility assessed by ultrasound elastography

Time Frame

48 weeks after intervention

Title

Quality of life monitoring - 1

Description

Time Frame

48 weeks after intervention

Title

Quality of life monitoring - 2

Description

Time Frame

48 weeks after intervention

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Georgy Dimov, PhD

Organizational Affiliation

South Ural State Medical University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Viacheslav Vasilyev, PhD

Organizational Affiliation

South Ural State Medical University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Zhanna Teryushkova, PhD

Organizational Affiliation

South Ural State Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

South Ural State Medical University

City

Chelyabinsk

State/Province

Chelyabinsk Oblast

ZIP/Postal Code

454092

Country

Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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