Rectovaginal FistulaPhase 1NCT03643614
Autologous Adipose-derived Regenerative Cells Injection for Treatment of Radiation-induced Rectovaginal Fistula
A Phase 1 study testing Injection of autologous regenerative cells of adipose tissue in people with Rectovaginal Fistula, run by South Ural State Medical University at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Rectovaginal Fistula
- What is being tested?
- Injection of autologous regenerative cells of adipose tissue
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteRussia
- Study dates
- 1 Aug 2017to 22 Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
South Ural State Medical University
Chelyabinsk, Chelyabinsk Oblast, 454092
About this study
Official title: Evaluation of Effectiveness and Safety of Autologous Adipose-derived Regenerative Cells Injection for Treatment of Radiation-induced Rectovaginal Fistula
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
- Being tested
- Injection of autologous regenerative cells of adipose tissue
- Keywords
- adipose derived stromal cells, stromal vascular fraction, mesenchymal stem cells, rectovaginal fistula
- Medical subject headings
- Rectovaginal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of autologous regenerative cells of adipose tissueProcedure or surgery
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 | Role | What they receive |
|---|---|---|
| study group | Experimental | Injection of autologous regenerative cells of adipose tissue for treatment of radiation induced rectovaginal fistulas Receives: Procedure: Injection of autologous regenerative cells of adipose tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious adverse events
Frequency, type and severity of serious adverse events (SAE)
Measured: 4 weeks after injection of adipose-derived regenerative cells
Serious adverse reactions
Frequency, type and severity of serious adverse reactions (SAR)
Measured: 4 weeks after injection of adipose-derived regenerative cells
Secondary outcomes (4)
Changes of fistula size
Intervention impact on dimensions of rectovaginal fistula
Measured: 48 weeks after intervention
Changes in rectovaginal soft tissue density and flexibility
Intervention impact on soft tissue density and flexibility assessed by ultrasound elastography
Measured: 48 weeks after intervention
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
Measured: 48 weeks after intervention
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.
Measured: 48 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start1 Aug 2017
- Primary completion15 Nov 2019
- Study completion22 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectovaginal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Ural State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georgy Dimov, PhD, Study chair, South Ural State Medical UniversityViacheslav Vasilyev, PhD, Study director, South Ural State Medical UniversityZhanna Teryushkova, PhD, Principal investigator, South Ural State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643614
- Sponsor's protocol ID
- RU SUSMU 310855.210617.1
- Status last verified
- Jan 2020
- First submitted
- 21 Aug 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of Autologous Adipose-derived Regenerative Cells Injection for Treatment of Radiation-induced Rectovaginal Fistula
- ClinicalTrials.gov ID
- NCT03643614
- Acronym / sponsor ID
- RU SUSMU 310855.210617.1
- Conditions
- Rectovaginal Fistula
- Keywords
- adipose derived stromal cells, stromal vascular fraction, mesenchymal stem cells, rectovaginal fistula
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- South Ural State Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Procedure: Injection of autologous regenerative cells of adipose tissueInjection of autologous regenerative cells of adipose tissue for treatment of radiation induced rectovaginal fistulas |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of autologous regenerative cells of adipose tissueAutologous 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. | Procedure or surgery | study group |
Primary outcome
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)
4 secondary outcomes
Changes of fistula size
Time frame: 48 weeks after intervention
Changes in rectovaginal soft tissue density and flexibility
Time frame: 48 weeks after intervention
Quality of life monitoring - 1
Time frame: 48 weeks after intervention
Quality of life monitoring - 2
Time frame: 48 weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgy Dimov, PhD study chair
South Ural State Medical University
Viacheslav Vasilyev, PhD study director
South Ural State Medical University
Zhanna Teryushkova, PhD principal investigator
South Ural State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Injection of autologous regenerative cells of adipose tissue in people with Rectovaginal Fistula, run by South Ural State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious adverse events (time frame: 4 weeks after injection of adipose-derived regenerative cells). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.