Mesenchymal Stem Cell Therapy (MSCs) and Conditioned Medium Therapy for Osteoartrithis (NCT04314661) | Clinical Trial Compass
CompletedPhase 1/2
Mesenchymal Stem Cell Therapy (MSCs) and Conditioned Medium Therapy for Osteoartrithis
Indonesia31 participantsStarted 2020-08-03
Plain-language 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.
Who can participate
Age range
55 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analog Scale (VAS)
Timeframe: 1 month after injection
2
Visual Analog Scale (VAS)
Timeframe: 3 month after injection
3
Visual Analog Scale (VAS)
Timeframe: 6 month after injection
4
Western Ontario and McMaster Universities Osteoarthritis Index
Timeframe: 1 month after injection
5
Western Ontario and McMaster Universities Osteoarthritis Index
Timeframe: 3 month after injection
6
Western Ontario and McMaster Universities Osteoarthritis Index