Clinical trial NCT04314661: Mesenchymal Stem Cell Therapy (MSCs) and Conditioned Medium Therapy for Osteoartrithis
Official title: Innovative Osteoarthritis Therapy Using Combination of Mesenchymal Stem Cell (MSC) and Conditioned Medium (CM): A Comparative Study on Arthroscopy and Non-Arthroscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
Allogeneic Mesenchymal Stem Cells
Umbilical Cord
Conditioned Medium
Lead sponsor: PT. Prodia Stem Cell Indonesia
Sponsor class: INDUSTRY
First posted: 2020-03-19
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Arthroscopy + Booster, Arthroscopy + Pre-conditioning, Non-Arthroscopy + Booster, Non-Arthroscopy + Pre-conditioning.

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 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

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 1 month after injection
measure: Visual Analog Scale (VAS)
timeFrame: 3 month after injection
measure: Visual Analog Scale (VAS)
timeFrame: 6 month after injection
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 1 month after injection
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 3 month after injection
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 6 month after injection
Secondary outcomes:
measure: Laboratory Asessment
timeFrame: 2 weeks after injection
measure: Laboratory Asessment
timeFrame: 1 month after injection
measure: Laboratory Asessment
timeFrame: 3 months after injection
measure: Magnetic Resonance Imaging (MRI) T2 mapping
timeFrame: 6 month after injection
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Gatot Soebroto Hospital
state: DKI Jakarta
Study officials:
References: