Clinical trials
Clinical trials – Ongoing
Code: OA-orMSCp-02
Title: Autologous bone marrow-derived mesenchymal stem cells seeded on a 3D scaffold in treatment of knee cartilage defects. Prospective open-label study to assess safety and feasibility.
Study Site: Department of Orthopedics, Masaryk Hospital, Usti nad Labem, Czech Republic
Principal Investigator: Pavel Neckar, M.D.
Rationale: The treatment of articular cartilage defects is relatively difficult; if untreated, the defect typically leads to onset of arthrosis, but methods aiming at structural repair of the hyaline cartilage are limited and their efficacy remains disputable. Evidence accumulated during the last decade has shown that commonly used methods of cartilage treatment, such as the microfracturing technique, the application of osteochondral autografts or fresh osteochondral allografts, or even implantation of autologous cultivated chondrocytes, do not produce satisfactory clinical outcome. At the best, the defect is filled with fibrous or hyaline-like cartilage the biomechanical properties of which are markedly inferior compared to healthy hyaline cartilage, and normal function of the joint thus cannot be restored.
An alternative approach combines cellular and acellular elements in the surgical intervention: multipotent MSCs isolated from the patient´s bone marrow are expanded ex vivo under Good Manufacturing Practice (GMP) conditions and then implanted at the cartilage lesion site using commercially available 3D scaffold. The three-dimensional scaffolding material serves as the MSC suspension carrier but also is supposed to promote migration and differentiation of the stem cells that may result in a better healing of the cartilage defect.
Aims:
Primary: To assess the safety of a single dose of autologous MSCs seeded on a commercially available acellular 3D scaffold and fixed using autologous blood plasma in the repair of knee chondral lesions.
Secondary: To collect preliminary efficacy data from patient administered questionnaires (VAS, KOOS and Lysholm-Tegner scoring scale) and X-ray. To evaluate feasibility of the treatment in the current clinical practice.
Phase: All patients have undergone the treatment, data collection is undergoing.
Clinical trials - Completed or Terminated
Code: AMSC-BDT-001
Title: Utilization of Autologous Multipotent Mesenchymal Stem Cells in the Management of Large Skeletal Defects during Revision Total Hip Arthroplasty: a Prospective, Non-randomized, Open-Label Study to Assess the Safety and the Efficacy.
Study site: Department of Orthopedics, Medical Faculty of Charles University and Faculty Hospital in Hradec Kralove, Czech Republic
Principal Investigator: Pavel Sponer, M.D., Ph.D.
Sponsor: Medical Faculty of Charles University Hradec Kralove
Rationale: Revision total hip arthroplasty is one of the most frequently used surgical approaches in orthopedics. The use of autologous and allogenous bone grafts in reconstruction and healing of bone defects during this surgery is essential prerequisite for stability and long-term function of the re-implanted endoprosthesis. However, the amount of the autologous bone grafts is limited (particular in large bone defects), their harvesting prolongs the time of surgery and there are problems with donor site pain and morbidity. The main problem of allografts is risk of infectious disease transmission and the graft resorption. This risk is reduced in processed allografts but the processing itself adversely affects their mechanical and biological properties. To avoid limitations and complications of the autologous and allogenous bone grafts, combinations of synthetic beta-tricalcium phosphate biomaterial (acting as an osteoconductive matrix) and the patient’s own bone marrow stromal cells (supposed to significantly support and contribute to new bone formation) were used.
Aims:
Primary: Safety: To assess an absence of complications at the site of femoral bone defect.
Secondary: Safety: Incidence of other treatment - emergent adverse events. Overall safety.
Efficacy: To assess the quality of healing of femoral bone defects measured according to Harris Hip Score, plain X-rays and densitometry.
The results of the clinical trial AMSC-BDT-001 have been published in Biomed .Res. Int. and Cell Transplantation journals (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4838782/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6180724/)