Treatment of Patients With Trophic Ulcers Using Mesenchymal Stem Cells

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Status and phase: Completed; Phase 2; Phase 1

Conditions: Trophic Ulcer

Treatments: Biological: Autologous adipose-derived mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04457037

IBCE_MSC(TrophicUlcer)

Details and patient eligibility

About

Treatment of patients with trophic ulcers using injection of autologous adipose-derived mesenchymal stem cells around and inside the wound

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Trophic Ulcers

Exclusion criteria

• diagnosed cancer
• acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
• mental disorders
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

MSC

Experimental group

Description:

Patients with trophic ulcers received standard treatment and MSC

Treatment:

Biological: Autologous adipose-derived mesenchymal stem cells