Umbilical cord-derived Wharton’s jelly for treatment of knee osteoarthritis: study protocol for a non-randomized, open-label, multi-center trial
| Autor: | Nicola Maffulli, Ashim Gupta, Howard J. Levy, Saadiq F. El-Amin, Hugo C. Rodriguez, Cassidy E. Lee |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Cartilage
Articular medicine.medical_specialty lcsh:Diseases of the musculoskeletal system Bone Regeneration Hyaluronic acid Osteoarthritis Biologics Exosomes Regenerative Medicine Umbilical cord Injections Intra-Articular Umbilical Cord Study Protocol lcsh:Orthopedic surgery RC925 Internal medicine Wharton's jelly medicine Humans Orthopedics and Sports Medicine Prospective Studies Wharton Jelly Prospective cohort study Wharton’s jelly business.industry Cartilage Extracellular vesicles Osteoarthritis Knee medicine.disease Clinical trial lcsh:RD701-811 medicine.anatomical_structure Inclusion and exclusion criteria Orthopedic surgery Intercellular Signaling Peptides and Proteins Surgery Knee osteoarthritis lcsh:RC925-935 Growth factors business Follow-Up Studies |
| Zdroj: | Journal of Orthopaedic Surgery and Research Journal of Orthopaedic Surgery and Research, Vol 16, Iss 1, Pp 1-7 (2021) |
| ISSN: | 1749-799X |
| DOI: | 10.1186/s13018-021-02300-0 |
| Popis: | Background Osteoarthritis (OA) is the most common joint disorder in the USA, and knee OA has the highest prevalence. Inflammation and decrease in vascularization are key factors in the degeneration of articular cartilage and the associated pain and decrease in function. To combat this process, the use of biologics including umbilical cord-derived Wharton’s Jelly (UC-derived WJ) has grown. UC-derived WJ contains large quantities of regenerative factors, including growth factors (GFs), cytokines (CKs), hyaluronic acid (HA), and extracellular vesicles (EVs). The proposed study evaluates the safety and efficacy of intraarticular injection of UC-derived WJ for treatment of knee OA symptoms. Methods and analysis This is a non-randomized, open-label, multi-center, prospective study in which the safety and efficacy of intraarticular UC-derived WJ in patients suffering from grade II/III OA will be assessed. Twelve patients with grade II/III OA who meet the inclusion and exclusion criteria will be recruited for this study which will be conducted at up to two sites within the USA. The participants will be followed for 1 s. Participants will be assessed using the Numeric Pain Rating Scale (NPRS), Knee Injury and Osteoarthritis Outcome Score (KOOS), 36-item short form survey (SF-36), Single Assessment Numeric Evaluation (SANE), physical exams, plain radiography, and Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score for improvements in pain, satisfaction, function, and cartilage regeneration. Discussion This prospective study will contribute to the limited amount of data on UC-derived WJ, particularly with regard to its safety and efficacy. The outcomes from this study will also lay the groundwork for a large placebo-controlled trial of intraarticular UC-derived WJ for symptomatic knee OA. Trial registration ClinicalTrials.gov NCT04719793. Registered on 22 January 2021 |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full text from SpringerLink