Osteoarthritis, Knee
Conditions
Keywords
Osteoarthritis, Allogeneic Mesenchymal Stem Cells, Umbilical Cord, Conditioned Medium
Brief summary
This study aims to compare the efficacy of Umbilical Cord Mesenchymal Stem Cell and secretome between arthroscopy and without arthroscopy intervention in OA patients. This study has 4 arms namely Arthroscopy + Booster, Arthroscopy + Pre-conditioning, Non-Arthroscopy + Booster, Non-Arthroscopy + Pre-conditioning.
Detailed description
The study subjects each group amounted to 5 patients suffering from osteoarthritis. Patients are evaluated before, and 1,3,6 months after injection.
Interventions
BIOLOGICALArthroscopy with Mesenchymal Stem Cells + Secretome + Secretome
After Arthroscopy intervention, patient recieve 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, two weeks afterward, patient receive 2 cc Secretome, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.
BIOLOGICALArthroscopy with Secretome + Mesenchymal Stem Cells + Secretome
After Arthroscopy intervention, patient recieve 2 cc Secretome, two weeks afterward patient receive 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.
BIOLOGICALNon Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome
Without Arthroscopy intervention, patient recieve 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, two weeks afterward, patient receive 2 cc Secretome, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.
BIOLOGICALNon Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome
Without Arthroscopy intervention, patient recieve 2 cc Secretome, two weeks afterward patient receive 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular.
Sponsors
PT. Prodia Stem Cell Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 55-70 years * Suffering from grade 2-3 OA was identified by two observers who differed accordingly Kellgren-Lawrence research scale * Absence of local or general infections * Haematological and biochemical analysis without significant changes being made cause contraindications * Patients can understand the nature of the study * Written informed consent is given to patients
Exclusion criteria
* Patients are not willing to obey the study protocol * There are signs of infection or positive serology for HIV, hepatitis and syphilis * There is a history of cancer both in the family and yourself and the value of the examination tumour marker exceeds normal limits * There is a congenital disease that causes significant deformity of the knee can interfere with cell applications and interpret results * Articular injection of the knee by any drug during the previous 3 months * Participate in any clinical trial or treatment 30 days before the study * Other conditions may, according to medical criteria, not support participation in this research * Patients are subordinates or low ranking members
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | 1 month after injection | To asses pain score, score 1(good)-10(worst) |
| Western Ontario and McMaster Universities Osteoarthritis Index | 1 month after injection | To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laboratory Asessment | 2 weeks after injection | COMP, MMP-13, IL-6 |
| Magnetic Resonance Imaging (MRI) T2 mapping | 6 month after injection | MRI T2 mapping is used for cartilage evaluation |
Countries
Indonesia
Outcome results
None listed