Status:
UNKNOWN
Mesenchymal Stem Cell Therapy (MSCs) and Conditioned Medium Therapy for Osteoartrithis
Lead Sponsor:
PT. Prodia Stem Cell Indonesia
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
55-70 years
Phase:
PHASE1
PHASE2
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 Arth...
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 8 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04314661
Start Date
August 3 2020
End Date
December 8 2024
Last Update
September 28 2022
Active Locations (1)
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1
Gatot Soebroto Hospital
Jakarta Pusat, DKI Jakarta, Indonesia, 10410