Autologous Adipose-derived Regenerative Cells Injection for Treatment of Radiation-induced Rectovaginal Fistula
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|ClinicalTrials.gov Identifier: NCT03643614|
Recruitment Status : Completed
First Posted : August 23, 2018
Last Update Posted : January 27, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Rectovaginal Fistula||Procedure: Injection of autologous regenerative cells of adipose tissue||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Effectiveness and Safety of Autologous Adipose-derived Regenerative Cells Injection for Treatment of Radiation-induced Rectovaginal Fistula|
|Actual Study Start Date :||August 1, 2017|
|Actual Primary Completion Date :||November 15, 2019|
|Actual Study Completion Date :||January 22, 2020|
Experimental: study group
Injection of autologous regenerative cells of adipose tissue for treatment of radiation induced rectovaginal fistulas
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.
- Serious adverse events [ Time Frame: 4 weeks after injection of adipose-derived regenerative cells ]Frequency, type and severity of serious adverse events (SAE)
- Serious adverse reactions [ Time Frame: 4 weeks after injection of adipose-derived regenerative cells ]Frequency, type and severity of serious adverse reactions (SAR)
- Changes of fistula size [ Time Frame: 48 weeks after intervention ]Intervention impact on dimensions of rectovaginal fistula
- Changes in rectovaginal soft tissue density and flexibility [ Time Frame: 48 weeks after intervention ]Intervention impact on soft tissue density and flexibility assessed by ultrasound elastography
- Quality of life monitoring - 1 [ Time Frame: 48 weeks after intervention ]
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:
- physical functioning
- bodily pain
- general health perceptions
- physical role functioning
- emotional role functioning
- social role functioning
- mental health
- Quality of life monitoring - 2 [ Time Frame: 48 weeks after intervention ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03643614
|South Ural State Medical University|
|Chelyabinsk, Chelyabinsk Oblast, Russian Federation, 454092|
|Study Chair:||Georgy Dimov, PhD||South Ural State Medical University|
|Study Director:||Viacheslav Vasilyev, PhD||South Ural State Medical University|
|Principal Investigator:||Zhanna Teryushkova, PhD||South Ural State Medical University|