Trophic UlcerPhase 1/2NCT04457037
Treatment of Patients With Trophic Ulcers Using Mesenchymal Stem Cells
A Phase 1/2 study testing Autologous adipose-derived mesenchymal stem cells in people with Trophic Ulcer, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
Trial summary
Treatment of patients with trophic ulcers using injection of autologous adipose-derived mesenchymal stem cells around and inside the wound Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Trophic Ulcer
- What is being tested?
- Autologous adipose-derived mesenchymal stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Oct 2009to 31 Dec 2013
- Phase
- Phase 1/2
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Trophic Ulcers
Who cannot join
- diagnosed cancer
- acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
- mental disorders
- pregnancy
Trial locations and contacts
1 site in 1 country.
Belarus1 site
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Minsk, 220072
About this study
Official title: Treatment of Patients With Trophic Ulcers Using Autologous Adipose-derived Mesenchymal Stem Cells
Treatment of patients with trophic ulcers using injection of autologous adipose-derived mesenchymal stem cells around and inside the wound
Read the detailed description
During the implementation of the project, it was planned to develop a method for the treatment of trophic ulcers using injection of autologous adipose-derived mesenchymal stem cells in the wound. The positive outlook for the effectiveness of MSCs is due to the following:
- the ability of MSCs to stimulate tissue regeneration
- positive results of preclinical studies of the method of treatment of trophic ulcers in animals (rats).
In study were included 18 patients (28 trophic ulcers treated). MSCs will be isolated from adipose tissue, cultured and then transplanted back to the wound. From 1 to 10 million MSCs in 4 ml were injected depending on the area of the wound. Follow up patients monitoring will occur at 1，2 and 3, 6, 12, 22 months after injection.
- Conditions
- Trophic Ulcer
- Being tested
- Autologous adipose-derived mesenchymal stem cells
- Keywords
- Trophic Ulcer, Mesenchymal stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous adipose-derived mesenchymal stem cellsBiological
Autologous adipose-derived mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| MSC | Experimental | Patients with trophic ulcers received standard treatment and MSC Receives: Biological: Autologous adipose-derived mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with tropic ulcers cured
Number of patients cured
Measured: 1 month
Number of patients with treatment-related adverse events
MSC injection related adverse events assessed by blood count and function tests
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Oct 2009
- Primary completion31 Dec 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trophic UlcerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with trophic ulcers received standard treatment and mesenchymal stem cells
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
- Sponsor type
- Other government
- Collaborators
- Belarusian State Medical University
- Responsible party
- Sponsor
- Investigators
- Igor Volotovski, Dr, Study director, Head of the Lab of Institute of Biophysics and Cell EngineeringStanislav Tretyak, Prof, Study director, Head of 2 Department of Surgical Diseases of BSMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457037
- Sponsor's protocol ID
- IBCE_MSC(TrophicUlcer)
- Status last verified
- Jun 2020
- First submitted
- 30 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Trophic Ulcers Using Autologous Adipose-derived Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT04457037
- Acronym / sponsor ID
- IBCE_MSC(TrophicUlcer)
- Conditions
- Trophic Ulcer
- Keywords
- Trophic Ulcer, Mesenchymal stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusOther government
- Collaborators
- Belarusian State Medical University
- Study start
- 1 Oct 2009 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 7 Jul 2020 (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.
Treatment of patients with trophic ulcers using injection of autologous adipose-derived mesenchymal stem cells around and inside the wound
Detailed description
During the implementation of the project, it was planned to develop a method for the treatment of trophic ulcers using injection of autologous adipose-derived mesenchymal stem cells in the wound. The positive outlook for the effectiveness of MSCs is due to the following:
- the ability of MSCs to stimulate tissue regeneration
- positive results of preclinical studies of the method of treatment of trophic ulcers in animals (rats).
In study were included 18 patients (28 trophic ulcers treated). MSCs will be isolated from adipose tissue, cultured and then transplanted back to the wound. From 1 to 10 million MSCs in 4 ml were injected depending on the area of the wound. Follow up patients monitoring will occur at 1，2 and 3, 6, 12, 22 months after injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with trophic ulcers received standard treatment and mesenchymal stem cells
| Arm | Type | Receives |
|---|---|---|
| MSC | Experimental | Biological: Autologous adipose-derived mesenchymal stem cellsPatients with trophic ulcers received standard treatment and MSC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Trophic Ulcers
Key exclusion criteria (4 listed)
- diagnosed cancer
- acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
- mental disorders
- pregnancy
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 |
|---|---|---|
| Autologous adipose-derived mesenchymal stem cellsAutologous adipose-derived mesenchymal stem cells | Biological | MSC |
Primary outcome
Number of patients with tropic ulcers cured
Time frame: 1 month
Number of patients cured
Number of patients with treatment-related adverse events
Time frame: 4 weeks
MSC injection related adverse events assessed by blood count and function tests
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 7 Jul 2020.
- Individual participant dataSharing planned: No
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.
Igor Volotovski, Dr study director
Head of the Lab of Institute of Biophysics and Cell Engineering
Stanislav Tretyak, Prof study director
Head of 2 Department of Surgical Diseases of BSMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous adipose-derived mesenchymal stem cells in people with Trophic Ulcer, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
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 1 inclusion and 4 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 7 Jul 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 Belarus. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of patients with tropic ulcers cured (time frame: 1 month). 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 7 Jul 2020.