Autologous Adipose-derived Regenerative Cells Injection for Treatment of Radiation-induced Rectov… (NCT03643614) | Clinical Trial Compass
CompletedPhase 1
Autologous Adipose-derived Regenerative Cells Injection for Treatment of Radiation-induced Rectovaginal Fistula
Russia16 participantsStarted 2017-08-01
Plain-language 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.
Who can participate
Age range
20 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serious adverse events
Timeframe: 4 weeks after injection of adipose-derived regenerative cells
2
Serious adverse reactions
Timeframe: 4 weeks after injection of adipose-derived regenerative cells