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

Phase 1

Recruiting

• Conditions: Osteoarthritis, Knee
• Interventions: 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

• Registration Number: NCT04314661
• Lead Sponsor: PT. Prodia Stem Cell Indonesia

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.

Study Timeline

• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-19
• Study Start: 2020-08-03
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-25
• Last Update Posted: 2022-09-28
• Primary Completion: 2024-07-08
• Study Completion: 2024-12-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arthroscopy + Booster	Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome	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 + Pre-Conditioning	Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome	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.
Non Arthroscopy + Booster	Non Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome	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 + Pre-Conditioning	Non Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome	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.

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis Index	6 month after injection	To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.
Visual Analog Scale (VAS)	6 month after injection	To asses pain score, score 1(good)-10(worst)

Secondary Outcome Measures

Name	Time	Method
Laboratory Asessment	3 months after injection	COMP, MMP-13, IL-6
Magnetic Resonance Imaging (MRI) T2 mapping	6 month after injection	MRI T2 mapping is used for cartilage evaluation

Trial Locations

Locations (1)

Gatot Soebroto Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia