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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10410
      • Gatot Soebroto Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: 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.
Experimental: 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.	Biological: 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.
Experimental: 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.	Biological: 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.; Other Names: Secretome
Experimental: 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.	Biological: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: PT. Prodia Stem Cell Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Actual): July 8, 2024
• Study Completion (Actual): December 8, 2024

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Osteoarthritis; Allogeneic Mesenchymal Stem Cells; Umbilical Cord; Conditioned Medium
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy; Orthopedic Procedures; Metabolism; Metabolome; Arthroscopy; Secretome
• Other Study ID Numbers: CT/OA/02/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No