Cartilage Injury Clinical Trial
Official title:
Effectiveness of Autologous Platelet-rich Plasma on Knee Cartilage Injury: a Randomized, Controlled, Open-label Clinical Trial
To analyze the effectiveness of intra-articular injection of autologous PRP on knee cartilage repair and evaluating functional recovery of the knee joint in knee cartilage injury patients.
Recent studies have shown that platelets, which contain a large number of cytokines and
growth factors, can be beneficial in inflammatory response and postoperative bleeding,
infection, bone formation, injury, muscle strain, and soft tissue healing. Platelets release
a plethora of biologically active proteins to aggregate macrophages, mesenchymal stem cells
(MSCs) and osteoblasts, thereby promoting degradation and clearing necrotic tissue, thus
further activating wound healing. In fact, platelet-rich plasma (PRP) is now used clinically
to promote cartilage repair.
By retrieving the Web of Science, a study by Havva et al. reported the clinical use of
autologous PRP in 82 patients with advanced knee osteoarthritis with good outcomes. However,
the clinical applications of this treatment have not been adequately investigated in
randomized controlled trials. Given this, additional studies on the exact efficacy of this
treatment are indispensible.
Three similar trial protocols to the current trial include 'Treatment of Osteoarthritis by
Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells With Platelet Rich Plasma
(NCT02365142)', 'PRP vs HA Intra-articular Knee Injections for Cartilage Defects
(NCT02012530)', and 'Mesenchymal Stem Cells Enhanced With PRP Versus PRP In OA Knee
(MSCPRPOAK) (NCT01985633)'. In these trial protocols, knee injury extent and treatment
success were assessed by Osteoarthritis Score, Western Ontario and McMaster Universities
Osteoarthritis Index (WOMAC) and Visual Analog Scale (VAS) score as outcome measures.
However, there are several differences in the inclusion criteria and randomization of these
trials in comparison with the current trial protocol.
Since autologous PRP predominantly functions to relieve pain and inhibit inflammatory
responses, clinical injection of autologous PRP for cartilage injury can stimulate
chondrocyte growth and matrix metabolism. Existing evidence has shown that autologous PRP
can increase type II collagen production and reduce apoptosis in chondrocytes when combined
with autologous bone marrow-MSCs. Furthermore, PRP can improve cartilage degeneration and
inhibit the development of osteoarthritis (OA) when combined with hydrogel microspheres.
Accordingly, the clinical use of autologous PRP can alleviate the symptoms of OA, promote
recovery of motor function, and ultimately improve patient quality of life.
To date, the clinical use of low-dose autologous PRP has been reported to alleviate pain at
the injury site in the treatment of articular cartilage injury, and achieve cartilage repair
and proliferation by releasing growth factors that promote extracellular matrix synthesis
and vascular reconstruction. However, the clinical applications of autologous PRP have not
been systemically reported in randomized controlled clinical trials, leading to a lack of
objective evidence on its effectiveness.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03479775 -
Muscle Function and Traumatic Knee Injury in Sports
|
||
Recruiting |
NCT03321812 -
Clinical Study of Decalcification Bone Scaffold for Cartilage Lesions of the Knee
|
N/A | |
Recruiting |
NCT06082531 -
Effect of Platelet-rich Plasma (PRP) Injection on Knee Osteoarthritis
|
N/A | |
Completed |
NCT06078072 -
Biomaterials and Mesenchymal Stem/Stromal Cells in the Treatment of Knee Articular Surface Lesions
|
||
Completed |
NCT04889443 -
Spontaneous Healing of ARticular Cartilage (SHARC)
|
||
Completed |
NCT04118023 -
7T MRI to Evaluate Cartilage Defects in the Knee
|
||
Active, not recruiting |
NCT01458782 -
ACI-C Versus AMIC. A Randomized Trial Comparing Two Methods for Repair of Cartilage Defects in the Knee
|
N/A | |
Recruiting |
NCT03477942 -
Impact of Mesenchymal Stem Cells in Knee Osteoarthritis
|
Phase 1 | |
Completed |
NCT01473199 -
BioPoly RS Knee Registry Study for Cartilage Defect Replacement
|
N/A | |
Recruiting |
NCT05124613 -
The Impact of Covid-19 on Patients Waiting for Knee Surgery
|
||
Recruiting |
NCT06344481 -
The Hyalex First-in-Human Study
|
Phase 1 | |
Completed |
NCT04739930 -
Autologous Bone Marrow Concentrate in Knee Osteochondral Allograft Transplantation
|
N/A | |
Active, not recruiting |
NCT03873545 -
Prospective Evaluation of ProChondrix CR for Repair of Articular Cartilage Defects on Femoral Condyle and Patella
|
||
Recruiting |
NCT05328674 -
Clinical and Comparative Evaluation of the Treatment Results of Arthroscopic Reconstruction of Cartilage Defects in the Knee Joint With the Use of Autogenous Cartilage Graft With PRP GF (Platelet-rich Plasma With Growth Factors)
|
N/A | |
Recruiting |
NCT04184687 -
The Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction
|
N/A | |
Terminated |
NCT04301258 -
ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry
|
||
Completed |
NCT02696876 -
Synovium Brushing to Augmented Microfracture for Improved Cartilage Repair
|
N/A | |
Completed |
NCT02637505 -
Norwegian Cartilage Project - Microfracture
|
N/A | |
Recruiting |
NCT04135950 -
Prospective Registry of Anterior Cruciate Ligament Reconstructions
|
||
Completed |
NCT01041001 -
Study to Compare Efficacy and Safety of Cartistem and Microfracture in Patients With Knee Articular Cartilage Injury
|
Phase 3 |