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

PT. Prodia Stem Cell Indonesia

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Osteoarthritis, Knee

Treatments: 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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04314661

CT/OA/02/2022

Details and patient eligibility

About

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.

Full description

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

Enrollment: 20 estimated patients

Sex: All

Ages: 55 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Arthroscopy + Booster

Experimental group

Description:

After arthroscopy intervention, patient will be given 10 million UC-MSCs and 2 cc Secretome twice with 2 weeks interval via intra-articular injection.

Treatment:

Biological: Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome

Arthroscopy + Pre-Conditioning

Experimental group

Description:

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.

Treatment:

Biological: Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome

Non Arthroscopy + Booster

Experimental group

Description:

Without arthroscopy intervention, patient will be given 10 million UC-MSCs and 2 cc Secretome twice with 2 weeks interval via intra-articular injection.

Treatment:

Biological: Non Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome

Non Arthroscopy + Pre-Conditioning

Experimental group

Description:

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.

Treatment:

Biological: Non Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome