Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT04313894
Status:
UNKNOWN
Last Update Posted:
2020-03-18
First Post:
2019-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
WHARTON JELLY ORIGINATED MESENCHIAL STEM CELL in GONARTHROSIS
Sponsor:
TC Erciyes University
Organization:
Study Overview
Official Title:
THE EFFECTIVENESS of WHARTON JELLY ORIGINATED MESENCHIAL STEM CELL in TREATMENT of KNEE OSTEOARTHRITIS
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WHAMKO
Brief Summary:
Osteoarthritis (OA) is a progressive disease characterized by degeneration of the joint cartilage, which is involved in the immune system leading to proinflammatory cytokine and metalloproteinase release. Knee osteoarthritis is the most common form. The healing is very slow and the damage is not fully recovered, so the degeneration process continues and no treatment modalities completely remove this process. Various methods are used in the treatment of OA and total joint replacement is performed in the patients with OA recently.
Ten patients with Kellgren-Lawrence grade II-III knee OA who had been applied for knee pain and received conservative treatment for 6 months and had no benefit will be taken to study. Patients will be assessed 7 (V1-7) times during the study. Clinical, immunologic and radiological treatment effectiveness and clinical improvement will be evaluated at the beginning of the treatment and in all follow-up patients participating in the study.
Ten patients with Kellgren-Lawrence grade II-III knee OA who had been applied for knee pain and received conservative treatment for 6 months and had no benefit will be taken to study. Patients will be assessed 7 (V1-7) times during the study. Clinical, immunologic and radiological treatment effectiveness and clinical improvement will be evaluated at the beginning of the treatment and in all follow-up patients participating in the study.
Detailed Description:
Osteoarthritis (OA) is a progressive disease characterized by degeneration of the articular cartilage, caused with the release of proinflammatory cytokines and metalloproteinases. Knee osteoarthritis is the most common form. OA accounts for about 2% of public health problems and leads to a reduction in production, resulting in indirect costs. Regardless of the etiology (age, trauma, overuse, autoimmune arthritis, infection, etc.), the recovery is very slow, the damage is not fully recovered, and the result is secondary fibrosis healing. Therefore, the degeneration process continues and no treatment modality does not completely eliminate this process. Various methods are used in the treatment of OA. The most commonly used of these methods are the physical and educational therapy offered by the American Society of Orthopedic Surgeons (AAOS), symptomatic treatment with acetaminophen and non-steroidal anti-inflammatory drugs, and steroid injection. In patients with end-stage OA who do not benefit from these treatment methods, total joint replacement is performed. Mesenchymal stem cells are multiple potent progenitor cells. In recent years, there have been promising developments in the treatment of patients who cannot be cured by stem cell therapy. Mesenchymal stem cells have been used in clinical and experimental animal studies due to their immunosuppressive effects, limited immunogenetic effects, their ability to be produced in culture and their multilevel structure. At the same time, studies have shown that mesenchymal stem cells have potential to differentiate into osteocytes, chondrocytes, muscle cells and nerve cells. Because of these features, mesenchymal stem cells have been used clinically for OA treatment. In addition, studies have shown that mesenchymal stem cells can be obtained from bone marrow, periosteum, trabecular bone, fat tissue, synovia, muscle tissue, milk tooth, umbilical cord and Wharton gel. Wharton gel is a mucous connective tissue in the umbilical cord and consists of myofibroblast-like stromal cells, collagen fibers, proteoglycans and hyaluronic acid. Because of these properties, it can be used as a source of stem cells.
dipocytokines are cytokines secreted from adipose tissue and act as intercellular signal proteins. These cytokines include adipose tissue and cells nutrient uptake, regulation of energy balance, insulin activation, lipid and glucose metabolism, angiogenesis, regulation of blood pressure, coagulation, immunostimulation, pro-inflammatory and anti-inflammatory effects.
Stem cell applications are now widely used in different tissues. In the recovery of chondral damage; Since cells have little capacity for regeneration and proliferation, stem cell derived differentiation is needed. In this study, it will be tried to show that chondral damage can be treated with wharton gel-derived stem cells.
dipocytokines are cytokines secreted from adipose tissue and act as intercellular signal proteins. These cytokines include adipose tissue and cells nutrient uptake, regulation of energy balance, insulin activation, lipid and glucose metabolism, angiogenesis, regulation of blood pressure, coagulation, immunostimulation, pro-inflammatory and anti-inflammatory effects.
Stem cell applications are now widely used in different tissues. In the recovery of chondral damage; Since cells have little capacity for regeneration and proliferation, stem cell derived differentiation is needed. In this study, it will be tried to show that chondral damage can be treated with wharton gel-derived stem cells.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: