The objective of our study is to compare the safety and effectiveness of the use of autologous cultured adipose tissue-derived stem cells versus cultured autologous chondrocytes for the treatment of chondral knee lesions.
Chondral knee lesions are frequent and produce important functional limitations and arthrosis development. Arthrosis is one of the most important causes of disability and its treatment with prosthetic surgery is associated with a high cost, and is not free of other complications. Several studies of cell therapy with autologous chondrocytes have shown efficacy in the treatment of this type of lesions, and currently is a common technique for the treatment of focal lesions of articular cartilage. Autologous chondrocyte transplant is associated with morbidity of the cartilage sample removal, which needs intra-articular surgery, and the limited tissue sample for culture. Adipose tissue-derived mesenchymal stem cells (ASC) have demonstrated chondrocytic differentiation and have been used in animal models for articular cartilage repair. Adipose tissue yields more ASC than chondrocytes are obtained from cartilage, and liposuction is simple and with less adverse events than arthroscopy. It is worth mentioned that culture conditions are less stringent for ASC than for chondrocytes, in terms of number of passages to obtain the amount of cells needed for implantation. We propose a randomized clinical trial, in which we compare the surgical implantation of either autologous chondrocytes or autologous ASC to treat chondral knee lesions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Implantation of autologous ASC or chondrocytes, 1 million per cm² lesion, covered by autologous periosteal membrane
La Paz University Hospital. Orthopedic Surgery and Traumatology Department, Knee Unit; Cell Therapy Laboratory.
Madrid, Madrid, Spain
Hyaline cartilage production for chondral knee lesions repair
Time frame: 18 months
Efficacy: Clinical evolution
Changes in Clinical tests and SF-12 Health Survey over 18 months
Time frame: 18 months
Efficacy: Functional evolution
Changes in Western Ontario-McMaster Osteoarthritis Score(WOMAC) over 18 months
Time frame: 18 months
Efficacy: Functional evolution
Changes in Knee Society Score(KSS) over 18 months
Time frame: 18 months
Efficacy: Histological evaluation
Hyaline cartilage production by histological methods at 18 months
Time frame: 18 months
Efficacy: Radiological evaluation
MRI at 18 months
Time frame: 18 months
Safety: Adverse events
Sistemic and local AEs especially attributable to implanted cells
Time frame: 18 months
Safety: Acute inflammatory events
Increase of pain of at least 30 mm on a 100 mm visual analog scale (VAS) along with self-reported swelling within 3 days post-cell application
Time frame: 18 months
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