Clinical trial NCT03643614: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rectovaginal Fistula
Keywords: adipose derived stromal cells
stromal vascular fraction
mesenchymal stem cells
rectovaginal fistula
Lead sponsor: South Ural State Medical University
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 16
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Serious adverse events
timeFrame: 4 weeks after injection of adipose-derived regenerative cells
measure: Serious adverse reactions
timeFrame: 4 weeks after injection of adipose-derived regenerative cells
Secondary outcomes:
measure: Changes of fistula size
timeFrame: 48 weeks after intervention
measure: Changes in rectovaginal soft tissue density and flexibility
timeFrame: 48 weeks after intervention
measure: Quality of life monitoring - 1
timeFrame: 48 weeks after intervention
measure: Quality of life monitoring - 2
timeFrame: 48 weeks after intervention
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: South Ural State Medical University
state: Chelyabinsk Oblast
Study officials:
affiliation: South Ural State Medical University
name: Georgy Dimov, PhD
role: STUDY_CHAIR
affiliation: South Ural State Medical University
name: Viacheslav Vasilyev, PhD
role: STUDY_DIRECTOR
affiliation: South Ural State Medical University
name: Zhanna Teryushkova, PhD
role: PRINCIPAL_INVESTIGATOR
References: