Treatment of knee cartilage by cultured stem cells and three dimensional scaffold: a phase I/IIa clinical trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00669806%3A_____%2F23%3A10445396" target="_blank" >RIV/00669806:_____/23:10445396 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11130/23:10445396 RIV/00216208:11140/23:10445396 RIV/00064203:_____/23:10445396
Result on the web
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=C_-Gw6FSeZ" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=C_-Gw6FSeZ</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1007/s00264-022-05505-y" target="_blank" >10.1007/s00264-022-05505-y</a>
Alternative languages
Result language
angličtina
Original language name
Treatment of knee cartilage by cultured stem cells and three dimensional scaffold: a phase I/IIa clinical trial
Original language description
PURPOSE: Damage of the knee cartilage is a common condition manifesting itself mainly by pain and/or swelling that may substantially reduce the quality of life while ultimately leading to osteoarthritis in affected patients. Here, we aimed to evaluate the safety and efficacy of cultured autologous bone marrow mesenchymal stem cells (BM-MSCs) attached to the 3D Chondrotissue(R) scaffold by autologous blood plasma coagulation (BiCure(R) ortho MSCp) in the treatment of knee cartilage defects. METHODS: The primary endpoint of this phase I/IIa clinical trial was to evaluate the safety of the treatment. The secondary objective was to determine the short-to-medium-term therapeutic outcomes by standardized scoring questionnaires including Lysholm Knee Scoring Scale (Lysholm score), Knee Injury and Osteoarthritis Outcome Score (KOOS), and pain Visual Analogue Scale (VAS) systems and imaging (X-ray and magnetic resonance imaging, MRI). A total of six patients were included and followed for 12 months after the surgery. RESULTS: BiCure(R) ortho MSCp was well tolerated with no adverse events associated with the investigational medicinal product. Significant improvements were observed in Lysholm scores and KOOS while X-ray showed no deterioration of the arthritis and MRI revealed a persistent filling of the chondral defects by the implant. CONCLUSION: Overall, our data demonstrate the safety of the tested investigational medicinal product. The function of the treated knee improved within one year after surgery in all enrolled patients. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: EudraCT No.: 2018-004,067-31; October 18 2018.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30211 - Orthopaedics
Result continuities
Project
—
Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2023
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
International Orthopaedics
ISSN
0341-2695
e-ISSN
1432-5195
Volume of the periodical
47
Issue of the periodical within the volume
10
Country of publishing house
DE - GERMANY
Number of pages
8
Pages from-to
2375-2382
UT code for WoS article
000827370400003
EID of the result in the Scopus database
2-s2.0-85134523577