Treatment of Patients With Trophic Ulcers Using Mesenchymal Stem Cells
- Conditions
- Trophic Ulcer
- Registration Number
- NCT04457037
- Brief Summary
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- Trophic Ulcers
- diagnosed cancer
- acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
- mental disorders
- pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of patients with tropic ulcers cured 1 month Number of patients cured
Number of patients with treatment-related adverse events 4 weeks MSC injection related adverse events assessed by blood count and function tests
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
🇧🇾Minsk, Belarus
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus🇧🇾Minsk, Belarus