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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04314661
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
PT. Prodia Stem Cell Indonesia

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

  1. There is an optimum improvement to the arthroscopy compared to without arthroscopy using UC-MSCs and CM UC-MSCs in osteoarthritis sufferers
  2. Reduced pain during joint rehabilitation and inflammation using UC-MSCs and CM UC-MSCs in patients with osteoarthritis.
  3. There are differences in functional scores of the knee joint after therapy using UC-MSCs and CM UC-MSCs in patients with osteoarthritis.
  4. There are differences in levels of inflammatory enzymes after therapy using UC-MSCs and CM UC-MSCs in patients with osteoarthritis.
  5. 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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : August 3, 2020
Estimated Primary Completion Date : September 8, 2020
Estimated Study Completion Date : December 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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 Name: Secretome




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: 2 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: 2 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: 6 weeks after injection ]
    COMP, MMP-13, IL-6

  2. Laboratory Asessment [ Time Frame: 12 weeks after injection ]
    COMP, MMP-13, IL-6

  3. Laboratory Asessment [ Time Frame: 24 weeks 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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

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
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Responsible Party: PT. Prodia Stem Cell Indonesia
ClinicalTrials.gov Identifier: NCT04314661    
Other Study ID Numbers: CT/OA/01/2020
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: March 2020

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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