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.
The study subjects each group amounted to 5 patients suffering from osteoarthritis. Patients are evaluated before, and 1,3,6 months after injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
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.
Gatot Soebroto Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
RECRUITINGVisual Analog Scale (VAS)
To asses pain score, score 1(good)-10(worst)
Time frame: 1 month after injection
Visual Analog Scale (VAS)
To asses pain score, score 1(good)-10(worst)
Time frame: 3 month after injection
Visual Analog Scale (VAS)
To asses pain score, score 1(good)-10(worst)
Time frame: 6 month after injection
Western Ontario and McMaster Universities Osteoarthritis Index
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.
Time frame: 1 month after injection
Western Ontario and McMaster Universities Osteoarthritis Index
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.
Time frame: 3 month after injection
Western Ontario and McMaster Universities Osteoarthritis Index
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.
Time frame: 6 month after injection
Laboratory Asessment
COMP, MMP-13, IL-6
Time frame: 2 weeks after injection
Laboratory Asessment
COMP, MMP-13, IL-6
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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.
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.
Time frame: 1 month after injection
Laboratory Asessment
COMP, MMP-13, IL-6
Time frame: 3 months after injection
Magnetic Resonance Imaging (MRI) T2 mapping
MRI T2 mapping is used for cartilage evaluation
Time frame: 6 month after injection