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Implantation of Allogenic Mesenchymal Stem Cell From Umbilical Cord Blood for Osteoarthritis Management

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ClinicalTrials.gov Identifier: NCT03800810
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Ismail Hadisoebroto Dilogo, Indonesia University

Study Description
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Brief Summary:
Prevalence of osteoarthritis increases every year, as a chronic and progressive disease. Osteoarthritis also gives many negative impacts in socio-economic life. Current management of osteoarthritis only aimed to relieve pain but not to resolve the degeneration of cartilage. Mesenchymal stem cell is one kind of adult stem cell that has potency in tissue engineering. Sources of mesenchymal stem cell are bone marrow, adipose tissue and umbilical cord. Researchers want to explore the potential of umbilical cord as the source of allogeneic MSC, because the gaining process of MSC is not invasive. Some countries have started some In vitro studies, Animal studies, and human research, but in Indonesia the study of mesenchymal stem cell implantation from umbilical cord in genu osteoarthritis management has not been reported. This study will be held into two years in Cipto Mangunkusumo Hospital and include 9 participants minimally. The researcher also compares the efficacy and safety of MSC implantation from umbilical cord applied to genu osteoarthritis with synovial artificial and recombinant human growth hormone therapy.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Hyaluronic Acid Biological: Umbilical Cord Mesenchymal Stem Cell Biological: Recombinant Human Somatropin Early Phase 1

Detailed Description:

This study is experimental clinical, randomized control trial. This study estimated time would be 24 months, from May 2016 until May 2018. Samples are obtained consecutively from all source population that meet criteria. This study divide the samples into three groups, synovial artificial group, MSC and synovial artificial combination group; MSC, Synovial, and recombinant human growth hormone group. The number of samples in each group is three.

Subject Criteria Inclusion Criteria for MSC Donor from Umbilical Cord:

Umbilical cord are collected from elective caesarean section from a fullterm pregnancies without any complication and free from HIV, Hepatitis B, C, D virus, Cytomegalovirus, Rubella Virus, and free from fungal and bacterial contamination.

Recipient inclusion criteria of osteoarthritis samples are patients aged 30-80 years old, based on genu X-ray examination and Kellgren-Lawrence grading is I, II, and III, or KL grade III with corrective osteotomy, minimal Visual Analog Scale = 2 (0-10), unresponsive with pharmacological therapy, and also sign up the informed consent.

Recipient exclusion criteria are Osteoarthritis KL grade IV, and secondary osteoarthritis due to trauma, infection, rheumatoid arthritis, congenital diseases, and autoimmune diseases, hypersensitivity of hyaluronan product, cancer, pregnant women.

Drop Out Criteria patients are ruled out from this study while the research are held or they undergo another treatment that are not related to this study. All drop out subjects could get another treatment.

Informed consent all of subjects must be filled and signed up before ruled in this study.

As soon as after delivery, umbilical cord is collected and processed in sterile specimen 0,9% NaCl at 4oC during 8 hours. The umbilical cord transported to the laboratory and cultured in GMP lab, at UPTTK Sel Punca Cipto Mangunkusumo Hospital. Cellular viability and proliferation are evaluated after cell characterization test by flowcytometer.

Sterility test are done three times to ensure cellular sterility. Subjects are positioned in supine position, site of injection are determined by the operator. Injection from superolateral or superomedial in extension knee position, injection from anterolateral or anteromedial in flexion knee position. Aseptic and antiseptic in site of injection use povidone iodine 3 times, then swab by alcohol. Local anesthetic by lidocaine 1% is injected subcutaneously.

Monitoring at the site of injection encompass allergic reaction, pain, and swelling. Patients are approached to be followed up every three months, in 1st ,3rd ,6th ,12th month, for clinical examination, VAS, IKDC and WOMAC Score. Cartigram MRI are evaluated every six month, in 6th and 12th month.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Potency of Allogenic Umbilical Cord Mesenchymal Stem Cells for Osteoarthritis Management
Study Start Date : May 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Control
Week 1: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis) Week 2: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis) Week 3: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis)
 Drug: Hyaluronic Acid
Other Name: Hyaluronan
Experimental: Intervention 1
Week 1: Intraarticular injection of 10x10^6 unit of umbilical cord mesenchymal stem cells in 2 ml conditioned medium, 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis) Week 2: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis), 8 IU recombinant human somatropin (Novell-Eutropin®, Novell Pharmaceutical Laboratories) Week 3: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis), 8 IU recombinant human somatropin (Novell-Eutropin®, Novell Pharmaceutical Laboratories)
 Drug: Hyaluronic Acid
Other Name: Hyaluronan

Biological: Umbilical Cord Mesenchymal Stem Cell
Biological: Recombinant Human Somatropin
Experimental: Intervention 2
Week 1: Intraarticular injection of 10x10^6 unit of umbilical cord mesenchymal stem cells in 2 ml conditioned medium, 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis) Week 2: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis) Week 3: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis)
 Drug: Hyaluronic Acid
Other Name: Hyaluronan

Biological: Umbilical Cord Mesenchymal Stem Cell
Experimental: Intervention 3
Week 1: Intraarticular injection of 10x10^6 unit of umbilical cord mesenchymal stem cells in 2 ml conditioned medium, 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis) Week 2: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis), 8 IU recombinant human somatropin (Novell-Eutropin®, Novell Pharmaceutical Laboratories) Week 3: Intraarticular injection of 2 ml hyaluronic acid (Synvisc-One® Hylan G-F 20, Sanofi-Aventis), 8 IU recombinant human somatropin (Novell-Eutropin®, Novell Pharmaceutical Laboratories)
 Drug: Hyaluronic Acid
Other Name: Hyaluronan

Biological: Recombinant Human Somatropin


Outcome Measures
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Primary Outcome Measures :
  1. Cartilage T2 map score [ Time Frame: 6 months ]
    MRI examination of the knee with additional T2 mapping software CartiGram (GE Healthcare, USA). T2 map sequence are obtained from the medial and lateral aspect of both femoral and tibial cartilage.

  2. IKDC score [ Time Frame: 3 months ]

    Subjective assessment of knee function using the International Knee Documentation Committee Subjective Knee Evaluation form.

    Scale ranges from 1 to 100, higher value indicates higher function.


  3. WOMAC score [ Time Frame: 3 months ]

    Subjective assessment of knee function using the the Western Ontario and McMaster Universities Osteoarthritis Index.

    Scale ranges from 100% to 1%, lower value indicates higher function.


  4. VAS score [ Time Frame: 3 months ]
    VAS score is used to assess knee pain experienced by subjects.


Eligibility Criteria
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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:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 30-80 years old
  • Kellgren-Lawrence grade I, II, and III, or KL grade III with corrective osteotomy according to knee x-ray examination
  • Minimal VAS: 2
  • Unresponsive with pharmacological therapy
  • Signed the informed consent

Exclusion Criteria:

  • Osteoarthritis KL grade IV
  • Secondary osteoarthritis due to trauma, infection, rheumatoid arthritis, congenital diseases, autoimmune diseases
  • Hypersensitivity to hyaluronic acid
  • Malignancies (Previously or currently diagnosed)
  • Pregnancy
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): NCT03800810


Contacts
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Contact: Ismail H Dilogo, MD, PhD +622144539917 ismailorthofkui@yahoo.co.id
Contact: Tri Kurniawati, BSc +622144539917 selpuncarscm@yahoo.co.id

Locations
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Indonesia
Universitas Indonesia Recruiting
Jakarta Pusat, Jakarta, Indonesia, 10430
Contact: Tri Kurniawati, BSc    +622144539917    selpuncarscm@yahoo.co.id   
Principal Investigator: Ismail H Dilogo, MD, PhD         
Sponsors and Collaborators
Indonesia University
More Information
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Additional Information:
Lozada, CJ. Et al. Osteoarthritis  This link exits the ClinicalTrials.gov site Hamami, MB. Growth Hormone  This link exits the ClinicalTrials.gov site 12. Luijkx V, Pai V. Kellgren and Lawrence system for the classification of the osteoarthritis of the knee  This link exits the ClinicalTrials.gov site Anonimous. WOMAC index  This link exits the ClinicalTrials.gov site

Publications:
Solomon L, Warwic DJ, Nagayam S. Osteoarthritis. In : Apple's System if Orthopaedics and Fractures 8th Edition.oxford University Press. New York : 2001. P 77-90

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Responsible Party: Ismail Hadisoebroto Dilogo, Consultant, Department of Orthopaedics and Traumatology, Indonesia University
ClinicalTrials.gov Identifier: NCT03800810     History of Changes
Other Study ID Numbers: ISMMSCOA
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Name Gender Contact Address Sign up

Keywords provided by Ismail Hadisoebroto Dilogo, Indonesia University:
Osteoarthritis
Mesenchymal Stem Cells
Umbilical Cord

Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents