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TRAUMATOLOGY. BONE TISSUE DEFECTS

TRAUMATOLOGY. BONE TISSUE DEFECTS

SUBJECT

Topic

Evaluation of the safety and efficacy of transplantation of cultured autologous multipotent mesenchymal stromal cells from bone marrow in patients with prolonged bone fracture healing and in patients with traumatic bone tissue defects.

purpose

Evaluation of the safety and efficacy of injection and surgical methods of transplantation of cultured autologous multipotent mesenchymal stromal cells from human bone marrow in patients with prolonged bone fracture healing and in patients with traumatic defects of bone tissue of the limbs.

RESEARCH

Preparation

The product of cultured multipotent mesenchymal stromal cells from bone marrow, intended for use as a cell transplant for intracutaneous injection and transplantation as a cell suspension or osteopenogenic graft.

Dose

The number of transplanted cells is determined individually for each patient, with a count of at least 10⁶ cells per cm³ of interfragmental space.

principle

Two methods of cell transplant insertion have been used in this reserch:

injection method – cultured MSCs are introduced as suspensions of cultured autologous MSCs;
operative method – MSCs are transplanted in the form of a three-dimensional graft (TG) consisting of fibrin-derivative hydrogel and cell suspension of cultured autologous MSCs.

expected result

The presence of radiological signs of bone regenerate in the area of non-healing 6 months after the transplantation of MSCs in case of lower leg fractures, and 8 months after – in case of hip fractures.
Repeated transplantation is not required.
Achievement of consolidation of bone fragments and restoration of bone tissue defects according to X-ray or MRI examinations within 12 months after transplantation of MSCs. Physical examination over time does not reveal any pathological changes or clinically significant deviations, the laboratory examination data do not significantly change and do not go beyond the norm, the patient does not have symptoms of adverse reactions.

Study protocol