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

September 25, 2022 updated by: PT. Prodia Stem Cell Indonesia

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

Recruiting

Conditions

Intervention / Treatment

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 (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

53 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 1 month after injection
To asses pain score, score 1(good)-10(worst)
1 month after injection
Visual Analog Scale (VAS)
Time Frame: 3 month after injection
To asses pain score, score 1(good)-10(worst)
3 month after injection
Visual Analog Scale (VAS)
Time Frame: 6 month after injection
To asses pain score, score 1(good)-10(worst)
6 month after injection
Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame: 1 month after injection
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
Time Frame: 3 month after injection
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
Time Frame: 6 month after injection
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
Time Frame: 2 weeks after injection
COMP, MMP-13, IL-6
2 weeks after injection
Laboratory Asessment
Time Frame: 1 month after injection
COMP, MMP-13, IL-6
1 month after injection
Laboratory Asessment
Time Frame: 3 months after injection
COMP, MMP-13, IL-6
3 months after injection
Magnetic Resonance Imaging (MRI) T2 mapping
Time Frame: 6 month after injection
MRI T2 mapping is used for cartilage evaluation
6 month after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PT. Prodia Stem Cell Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2020

Primary Completion (Anticipated)

July 8, 2024

Study Completion (Anticipated)

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)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 25, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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