Trophic Ulcer
Conditions
Keywords
Trophic Ulcer, Mesenchymal stem cells
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.
Interventions
Autologous adipose-derived mesenchymal stem cells
Sponsors
Belarusian State Medical University
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients with trophic ulcers received standard treatment and mesenchymal stem cells
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Trophic Ulcers
Exclusion criteria
* diagnosed cancer * acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis * mental disorders * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belarus
Outcome results
None listed