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

Osteoarthritis, Knee Clinical Trial

— OA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04314661
• Other study ID #: CT/OA/02/2022
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 3, 2020
• Est. completion date: December 8, 2024

Study information

• Verified date: September 2022
• Source: PT. Prodia Stem Cell Indonesia
• Contact: Yanuarso Yanuarso, Master
• Phone: 081317128172
• Email: dryanuarso73[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study subjects each group amounted to 5 patients suffering from osteoarthritis. Patients are evaluated before, and 1,3,6 months after injection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 8, 2024
• Est. primary completion date: July 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Indonesia	Gatot Soebroto Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
PT. Prodia Stem Cell Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	To asses pain score, score 1(good)-10(worst)	1 month after injection
Primary	Visual Analog Scale (VAS)	To asses pain score, score 1(good)-10(worst)	3 month after injection
Primary	Visual Analog Scale (VAS)	To asses pain score, score 1(good)-10(worst)	6 month after injection
Primary	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
Primary	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
Primary	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	Laboratory Asessment	COMP, MMP-13, IL-6	2 weeks after injection
Secondary	Laboratory Asessment	COMP, MMP-13, IL-6	1 month after injection
Secondary	Laboratory Asessment	COMP, MMP-13, IL-6	3 months after injection
Secondary	Magnetic Resonance Imaging (MRI) T2 mapping	MRI T2 mapping is used for cartilage evaluation	6 month after injection