Mesenchymal Stem Cell Therapy (MSCs) and Conditioned Medium Therapy for Osteoartrithis

Study Overview
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Brief Summary
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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
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The study subjects each group amounted to 5 patients suffering from osteoarthritis. Patients are evaluated before, and 1,3,6 months after injection.

Official Title
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Innovative Osteoarthritis Therapy Using Combination of Mesenchymal Stem Cell (MSC) and Conditioned Medium (CM): A Comparative Study on Arthroscopy and Non-Arthroscopy

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Biological: Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome
* Biological: Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome
* Biological: Non Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome
* Biological: Non Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arthroscopy + Booster<br>After arthroscopy intervention, patient will be given 10 million UC-MSCs and 2 cc Secretome twice with 2 weeks interval via intra-articular injection. | Biological: Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome<br>* 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.<br>|
| Experimental: Arthroscopy + Pre-Conditioning<br>After arthroscopy intervention, patient will be given 2 cc Secretome, 10 million UC-MSCs, and 2 cc Secretome with 2 weeks interval via intra-articular injection. | Biological: Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome<br>* 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.<br>|
| Experimental: Non Arthroscopy + Booster<br>Without arthroscopy intervention, patient will be given 10 million UC-MSCs and 2 cc Secretome twice with 2 weeks interval via intra-articular injection. | Biological: Non Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome<br>* 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.<br>* Other names: Secretome;|
| Experimental: Non Arthroscopy + Pre-Conditioning<br>Without arthroscopy intervention, patient will be given 2 cc Secretome, 10 million UC-MSCs, and 2 cc Secretome with 2 weeks interval via intra-articular injection. | Biological: Non Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | To asses pain score, score 1(good)-10(worst) | 1 month after injection | 
| Visual Analog Scale (VAS) | To asses pain score, score 1(good)-10(worst) | 3 month after injection | 
| Visual Analog Scale (VAS) | To asses pain score, score 1(good)-10(worst) | 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. | 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. | 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. | 6 month after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory Asessment | COMP, MMP-13, IL-6 | 2 weeks after injection | 
| Laboratory Asessment | COMP, MMP-13, IL-6 | 1 month after injection | 
| Laboratory Asessment | COMP, MMP-13, IL-6 | 3 months after injection | 
| Magnetic Resonance Imaging (MRI) T2 mapping | MRI T2 mapping is used for cartilage evaluation | 6 month after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Allogeneic Mesenchymal Stem Cells, Umbilical Cord, Conditioned Medium