The regenerative technology for treating chronic wounds and trophic ulcers is indicated for patients with long-standing skin and soft tissue defects (more than 2 months), when inpatient treatment has been ineffective for six months, with ulcer recurrences more than once a year, and with multiple lesions.

The regenerative technology is based on SFs’ ability to accelerate the healing of wounds and trophic ulcers by affecting skin cell growth and division, extracellular matrix synthesis, growth factor production, and capillary formation.

Autologous SFs from the patient are used to produce BMCP. With local intradermal and application transplantation, SFs act as an effective regenerative (healing) factor, synthesizing collagen, acting as a «pump» for growth factor secretion, and then differentiating into skin or blood vessel cells, stimulating the patient’s regenerative processes.

The functional activity of SFs transplanted to the wound determines the rate of granulation tissue and epithelium formation and maturation, while SFs autocrine and paracrine effects (secreting a range of cytokines and growth factors) alter the wound process — activating repair, accelerating granulation tissue maturation, stimulating wound contraction, ultimately leading to faster epithelialization and shortening the full healing time of the ulcer defect.

Treatment Scheme

The biomaterial for obtaining FCs is skin.

Skin explantation is performed on an outpatient basis under local anesthesia by excision (or punch biopsy) of a small (0.5 cm²) area of skin behind the ear or on the inner surface of the arm.

The total dose of FCs in BMCP and the frequency of transplantations are determined individually based on the area and nature of the lesion.

The approximate therapeutic dose for a single transplantation is at least 100 thousand SFs per 1 cm² of defect area.

The time interval between skin explantation and the first transplantation is typically 30-35 days, determined by the growth rate of SFs.

The schedule of therapeutic dose transplantations is set individually and varies from 5-7 to 10-15 days or more.

The procedure for local injection (application) transplantation of BMCP is a minimally invasive surgical operation performed under local anesthesia in the CTD operating room.

Immediately after transplantation, the patient is observed for 1-2 hours in the day hospital ward. In the postoperative period, several dressings are required.

Effectiveness

The clinical result of the method is the elimination of pain, suppression of the inflammatory process in surrounding tissues, and healing and epithelialization of the trophic ulcer.

The severity and duration of the regenerative effect are primarily determined by the degree of microcirculation disruption in the limb and other factors (persistent wound infection, decompensated lymphatic-venous insufficiency).

Safety and Complications

Various congenital and genetic pathologies, autoimmune, infectious, and oncological diseases (even if successfully treated in the past) significantly reduce the effectiveness of cell therapy.

Chronic heart diseases, blood coagulation disorders, alcohol, and drug dependence significantly impact the clinical outcome.

The safety of the method concerning autoimmune, allergic, and infectious complications is ensured by using the patient’s own cells, eliminating the risk of transplant rejection and transmission of transmissible infections such as viral hepatitis and HIV.

Currently, there are no reported cases of oncological diseases resulting from the use of autologous FCs in scientific literature.

Despite comprehensive complication prevention, some general and local complications may develop during and after the procedure: hematoma formation, bleeding, wound suppuration, allergic reactions to the anesthetic.