Mesenchymal Stem Cell Therapy (MSCs) and Conditioned Medium Therapy for Osteoartrithis
NCT ID: NCT04314661
Last Updated: 2022-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2020-08-03
2024-12-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arthroscopy + Booster
After arthroscopy intervention, patient will be given 10 million UC-MSCs and 2 cc Secretome twice with 2 weeks interval via intra-articular injection.
Arthroscopy 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.
Arthroscopy + Pre-Conditioning
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.
Arthroscopy 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.
Non Arthroscopy + Booster
Without arthroscopy intervention, patient will be given 10 million UC-MSCs and 2 cc Secretome twice with 2 weeks interval via intra-articular injection.
Non 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.
Non Arthroscopy + Pre-Conditioning
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.
Non 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.
Interventions
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Arthroscopy 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.
Arthroscopy 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.
Non 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.
Non 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
70 Years
ALL
No
Sponsors
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PT. Prodia Stem Cell Indonesia
INDUSTRY
Responsible Party
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Locations
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Gatot Soebroto Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CT/OA/02/2022
Identifier Type: -
Identifier Source: org_study_id
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