OA: Comparative Effectiveness of Arthroscopy and Non-Arthroscopy Using Mesenchymal Stem Cell Therapy (MSCs) and Conditioned Medium for Osteoartrithis

Sponsor

PT. Prodia Stem Cell Indonesia (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04314661

Collaborator

(none)

Enrollment

Location

Arms

52.2

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The clinical trial will be carried out at the Gatot Soebroto Army Central Hospital, Jakarta and planned from October 2019 to April 2020. Clinical trials of UC-MSCs and CM UC MSCs against OA were designed in three groups with arthroscopy and without arthroscopy with each of the groups 1 and 2 were given 5 million UC-MSCs cells then continued with 2 cc UC-MSCs CM given twice at 2-week intervals, while group 3 were given 2cc CM-MSCs and continued with 2-cm CM-MSCs administration at intervals 2 weeks. The study subjects each group amounted to 5 patients suffering from osteoarthritis. Once a week, all subjects were given physiotherapy by a doctor. Patients were evaluated for 6 months after injection.

The hypothesis are

There is an optimum improvement to the arthroscopy compared to without arthroscopy using UC-MSCs and CM UC-MSCs in osteoarthritis sufferers
Reduced pain during joint rehabilitation and inflammation using UC-MSCs and CM UC-MSCs in patients with osteoarthritis.
There are differences in functional scores of the knee joint after therapy using UC-MSCs and CM UC-MSCs in patients with osteoarthritis.
There are differences in levels of inflammatory enzymes after therapy using UC-MSCs and CM UC-MSCs in patients with osteoarthritis.
There is a significant relationship between improvement in functional score of the knee joint with levels of inflammatory enzymes in osteoarthritis

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Biological: Mesenchymal Stem Cells with Arthoscopy Biological: Mesenchymal Stem Cells without Arthoscopy Biological: Conditioned Medium without Arthoscopy	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparative Effectiveness of Arthroscopy and Non-Arthroscopy Using Mesenchymal Stem Cell Therapy (MSCs) and Conditioned Medium From Mesenchymal Stem Cell Culture (MSCs) for Osteoartrithis With Controlled Randomization in Phase I/II

Actual Study Start Date :

Aug 3, 2020

Anticipated Primary Completion Date :

Jul 8, 2024

Anticipated Study Completion Date :

Dec 8, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arthoscopy + UC-MSCs + CM + CM After arthroscopy patient will be given UC-MSCs 5 million cells, after 2 weeks patient will be given CM 2 cc and after 2 weeks later the patient will be given CM 2 cc	Biological: Mesenchymal Stem Cells with Arthoscopy Arthroscopy treatment after that injection Allogeneic Umbilical Cord Mesenchymal Stem Cells 5 million cells in NaCL 5 cc, two weeks later injection with Conditioned Medium 2 cc/knee, four weeks later injection with Conditioned Medium 2 cc/knee. All injection via Intraarticular injection.
Experimental: Non Arthoscopy + UC-MSCs + CM + CM Patient will be given UC-MSCs 5 million cells, after 2 weeks patient will be given CM 2 cc and after 2 weeks later the patient will be given CM 2 cc	Biological: Mesenchymal Stem Cells with Arthoscopy Arthroscopy treatment after that injection Allogeneic Umbilical Cord Mesenchymal Stem Cells 5 million cells in NaCL 5 cc, two weeks later injection with Conditioned Medium 2 cc/knee, four weeks later injection with Conditioned Medium 2 cc/knee. All injection via Intraarticular injection. Biological: Mesenchymal Stem Cells without Arthoscopy Injection with Allogeneic Umbilical Cord Mesenchymal Stem Cells 5 million cells in NaCL 5 cc, two weeks later injection with Conditioned Medium Derived Umbilical Cord Mesenchymal Stem Cells 2 cc/knee, four weeks later injection with Conditioned Medium 2 cc/knee. All injection via Intraarticular injection.
Experimental: Non Arthoscopy + CM + CM Patient will be given CM 2 cc and after 2 weeks later the patient will be given CM 2 cc	Biological: Mesenchymal Stem Cells without Arthoscopy Injection with Allogeneic Umbilical Cord Mesenchymal Stem Cells 5 million cells in NaCL 5 cc, two weeks later injection with Conditioned Medium Derived Umbilical Cord Mesenchymal Stem Cells 2 cc/knee, four weeks later injection with Conditioned Medium 2 cc/knee. All injection via Intraarticular injection. Biological: Conditioned Medium without Arthoscopy Injection with Conditioned Medium Derived Umbilical Cord Mesenchymal Stem Cells 2 cc/knee, four weeks later injection with Conditioned Medium 2 cc/knee. All injection via Intraarticular injection. Other Names: Secretome

Arm

Intervention/Treatment

Experimental: Arthoscopy + UC-MSCs + CM + CM

After arthroscopy patient will be given UC-MSCs 5 million cells, after 2 weeks patient will be given CM 2 cc and after 2 weeks later the patient will be given CM 2 cc

Biological: Mesenchymal Stem Cells with Arthoscopy

Arthroscopy treatment after that injection Allogeneic Umbilical Cord Mesenchymal Stem Cells 5 million cells in NaCL 5 cc, two weeks later injection with Conditioned Medium 2 cc/knee, four weeks later injection with Conditioned Medium 2 cc/knee. All injection via Intraarticular injection.

Experimental: Non Arthoscopy + UC-MSCs + CM + CM

Patient will be given UC-MSCs 5 million cells, after 2 weeks patient will be given CM 2 cc and after 2 weeks later the patient will be given CM 2 cc

Biological: Mesenchymal Stem Cells with Arthoscopy

Biological: Mesenchymal Stem Cells without Arthoscopy

Injection with Allogeneic Umbilical Cord Mesenchymal Stem Cells 5 million cells in NaCL 5 cc, two weeks later injection with Conditioned Medium Derived Umbilical Cord Mesenchymal Stem Cells 2 cc/knee, four weeks later injection with Conditioned Medium 2 cc/knee. All injection via Intraarticular injection.

Experimental: Non Arthoscopy + CM + CM

Patient will be given CM 2 cc and after 2 weeks later the patient will be given CM 2 cc

Biological: Mesenchymal Stem Cells without Arthoscopy

Biological: Conditioned Medium without Arthoscopy

Injection with Conditioned Medium Derived Umbilical Cord Mesenchymal Stem Cells 2 cc/knee, four weeks later injection with Conditioned Medium 2 cc/knee. All injection via Intraarticular injection.

Other Names:

Secretome

Outcome Measures

Primary Outcome Measures

Visual Analog Scale (VAS) [1 month after injection]
To asses pain score, score 1(good)-10(worst)
Visual Analog Scale (VAS) [2 month after injection]
To asses pain score, score 1(good)-10(worst)
Visual Analog Scale (VAS) [6 month after injection]
To asses pain score, score 1(good)-10(worst)
Western Ontario and McMaster Universities Osteoarthritis Index [1 month after injection]
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.
Western Ontario and McMaster Universities Osteoarthritis Index [2 month after injection]
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.
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.

Secondary Outcome Measures

Laboratory Asessment [6 weeks after injection]
COMP, MMP-13, IL-6
Laboratory Asessment [12 weeks after injection]
COMP, MMP-13, IL-6
Laboratory Asessment [24 weeks 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients aged 55-70 years
Suffering from grade 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