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

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ClinicalTrials.gov Identifier: NCT04314661
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : September 28, 2022
Sponsor:
Information provided by (Responsible Party):
PT. Prodia Stem Cell Indonesia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee 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 Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Innovative Osteoarthritis Therapy Using Combination of Mesenchymal Stem Cell (MSC) and Conditioned Medium (CM): A Comparative Study on Arthroscopy and Non-Arthroscopy
Actual Study Start Date : August 3, 2020
Estimated Primary Completion Date : July 8, 2024
Estimated Study Completion Date : December 8, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Visual Analog Scale (VAS) [ Time Frame: 1 month after injection ]
    To asses pain score, score 1(good)-10(worst)

  2. Visual Analog Scale (VAS) [ Time Frame: 3 month after injection ]
    To asses pain score, score 1(good)-10(worst)

  3. Visual Analog Scale (VAS) [ Time Frame: 6 month after injection ]
    To asses pain score, score 1(good)-10(worst)

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. Laboratory Asessment [ Time Frame: 2 weeks after injection ]
    COMP, MMP-13, IL-6

  2. Laboratory Asessment [ Time Frame: 1 month after injection ]
    COMP, MMP-13, IL-6

  3. Laboratory Asessment [ Time Frame: 3 months after injection ]
    COMP, MMP-13, IL-6

  4. Magnetic Resonance Imaging (MRI) T2 mapping [ Time Frame: 6 month after injection ]
    MRI T2 mapping is used for cartilage evaluation


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04314661


Contacts
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Contact: Yanuarso Yanuarso, Master 081317128172 dryanuarso73@gmail.com
Contact: Cynthia Sartika, Doctor c.sartika@gmail.com

Locations
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Indonesia
Gatot Soebroto Hospital Recruiting
Jakarta Pusat, DKI Jakarta, Indonesia, 10410
Contact: Yanuarso, dr    08170147000    dryanuarso73@gmail.com   
Contact: Viana    081317128172    rahmawativiana@gmail.com   
Sponsors and Collaborators
PT. Prodia Stem Cell Indonesia
More Information
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Responsible Party: PT. Prodia Stem Cell Indonesia
ClinicalTrials.gov Identifier: NCT04314661    
Other Study ID Numbers: CT/OA/02/2022
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PT. Prodia Stem Cell Indonesia:
Osteoarthritis
Allogeneic Mesenchymal Stem Cells
Umbilical Cord
Conditioned Medium
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases