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

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome
Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome
Non Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome
Non Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome
Sponsored by
PT. Prodia Stem Cell Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Allogeneic Mesenchymal Stem Cells, Umbilical Cord, Conditioned Medium

Eligibility Criteria

55 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Gatot Soebroto HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Arthroscopy + Booster

Arthroscopy + Pre-Conditioning

Non Arthroscopy + Booster

Non Arthroscopy + Pre-Conditioning

Arm 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.

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.

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Laboratory Asessment
COMP, MMP-13, IL-6
Laboratory Asessment
COMP, MMP-13, IL-6
Laboratory Asessment
COMP, MMP-13, IL-6
Magnetic Resonance Imaging (MRI) T2 mapping
MRI T2 mapping is used for cartilage evaluation

Full Information

First Posted
February 19, 2020
Last Updated
September 25, 2022
Sponsor
PT. Prodia Stem Cell Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT04314661
Brief Title
Mesenchymal Stem Cell Therapy (MSCs) and Conditioned Medium Therapy for Osteoartrithis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
July 8, 2024 (Anticipated)
Study Completion Date
December 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PT. Prodia Stem Cell Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, Allogeneic Mesenchymal Stem Cells, Umbilical Cord, Conditioned Medium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arthroscopy + Booster
Arm Type
Experimental
Arm 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.
Arm Title
Arthroscopy + Pre-Conditioning
Arm Type
Experimental
Arm 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.
Arm Title
Non Arthroscopy + Booster
Arm Type
Experimental
Arm 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.
Arm Title
Non Arthroscopy + Pre-Conditioning
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Non Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome
Other Intervention Name(s)
Secretome
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Non Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
To asses pain score, score 1(good)-10(worst)
Time Frame
1 month after injection
Title
Visual Analog Scale (VAS)
Description
To asses pain score, score 1(good)-10(worst)
Time Frame
3 month after injection
Title
Visual Analog Scale (VAS)
Description
To asses pain score, score 1(good)-10(worst)
Time Frame
6 month after injection
Title
Western Ontario and McMaster Universities Osteoarthritis Index
Description
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.
Time Frame
1 month after injection
Title
Western Ontario and McMaster Universities Osteoarthritis Index
Description
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.
Time Frame
3 month after injection
Title
Western Ontario and McMaster Universities Osteoarthritis Index
Description
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints.
Time Frame
6 month after injection
Secondary Outcome Measure Information:
Title
Laboratory Asessment
Description
COMP, MMP-13, IL-6
Time Frame
2 weeks after injection
Title
Laboratory Asessment
Description
COMP, MMP-13, IL-6
Time Frame
1 month after injection
Title
Laboratory Asessment
Description
COMP, MMP-13, IL-6
Time Frame
3 months after injection
Title
Magnetic Resonance Imaging (MRI) T2 mapping
Description
MRI T2 mapping is used for cartilage evaluation
Time Frame
6 month after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanuarso Yanuarso, Master
Phone
081317128172
Email
dryanuarso73@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Sartika, Doctor
Email
c.sartika@gmail.com
Facility Information:
Facility Name
Gatot Soebroto Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10410
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanuarso, dr
Phone
08170147000
Email
dryanuarso73@gmail.com
First Name & Middle Initial & Last Name & Degree
Viana
Phone
081317128172
Email
rahmawativiana@gmail.com

12. IPD Sharing Statement

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

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