<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03800810</url>
  </required_header>
  <id_info>
    <org_study_id>ISMMSCOA</org_study_id>
    <nct_id>NCT03800810</nct_id>
  </id_info>
  <brief_title>Implantation of Allogenic Mesenchymal Stem Cell From Umbilical Cord Blood for Osteoarthritis Management</brief_title>
  <official_title>Potency of Allogenic Umbilical Cord Mesenchymal Stem Cells for Osteoarthritis Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indonesia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indonesia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prevalence of osteoarthritis increases every year, as a chronic and progressive disease.&#xD;
      Osteoarthritis also gives many negative impacts in socio-economic life. Current management of&#xD;
      osteoarthritis only aimed to relieve pain but not to resolve the degeneration of cartilage.&#xD;
      Mesenchymal stem cell is one kind of adult stem cell that has potency in tissue engineering.&#xD;
      Sources of mesenchymal stem cell are bone marrow, adipose tissue and umbilical cord.&#xD;
      Researchers want to explore the potential of umbilical cord as the source of allogeneic MSC,&#xD;
      because the gaining process of MSC is not invasive. Some countries have started some In vitro&#xD;
      studies, Animal studies, and human research, but in Indonesia the study of mesenchymal stem&#xD;
      cell implantation from umbilical cord in genu osteoarthritis management has not been&#xD;
      reported. This study will be held into two years in Cipto Mangunkusumo Hospital and include 9&#xD;
      participants minimally. The researcher also compares the efficacy and safety of MSC&#xD;
      implantation from umbilical cord applied to genu osteoarthritis with synovial artificial and&#xD;
      recombinant human growth hormone therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is experimental clinical, randomized control trial. This study estimated time&#xD;
      would be 24 months, from May 2016 until May 2018. Samples are obtained consecutively from all&#xD;
      source population that meet criteria. This study divide the samples into three groups,&#xD;
      synovial artificial group, MSC and synovial artificial combination group; MSC, Synovial, and&#xD;
      recombinant human growth hormone group. The number of samples in each group is three.&#xD;
&#xD;
      Subject Criteria Inclusion Criteria for MSC Donor from Umbilical Cord:&#xD;
&#xD;
      Umbilical cord are collected from elective caesarean section from a fullterm pregnancies&#xD;
      without any complication and free from HIV, Hepatitis B, C, D virus, Cytomegalovirus, Rubella&#xD;
      Virus, and free from fungal and bacterial contamination.&#xD;
&#xD;
      Recipient inclusion criteria of osteoarthritis samples are patients aged 30-80 years old,&#xD;
      based on genu X-ray examination and Kellgren-Lawrence grading is I, II, and III, or KL grade&#xD;
      III with corrective osteotomy, minimal Visual Analog Scale = 2 (0-10), unresponsive with&#xD;
      pharmacological therapy, and also sign up the informed consent.&#xD;
&#xD;
      Recipient exclusion criteria are Osteoarthritis KL grade IV, and secondary osteoarthritis due&#xD;
      to trauma, infection, rheumatoid arthritis, congenital diseases, and autoimmune diseases,&#xD;
      hypersensitivity of hyaluronan product, cancer, pregnant women.&#xD;
&#xD;
      Drop Out Criteria patients are ruled out from this study while the research are held or they&#xD;
      undergo another treatment that are not related to this study. All drop out subjects could get&#xD;
      another treatment.&#xD;
&#xD;
      Informed consent all of subjects must be filled and signed up before ruled in this study.&#xD;
&#xD;
      As soon as after delivery, umbilical cord is collected and processed in sterile specimen 0,9%&#xD;
      NaCl at 4oC during 8 hours. The umbilical cord transported to the laboratory and cultured in&#xD;
      GMP lab, at UPTTK Sel Punca Cipto Mangunkusumo Hospital. Cellular viability and proliferation&#xD;
      are evaluated after cell characterization test by flowcytometer.&#xD;
&#xD;
      Sterility test are done three times to ensure cellular sterility. Subjects are positioned in&#xD;
      supine position, site of injection are determined by the operator. Injection from&#xD;
      superolateral or superomedial in extension knee position, injection from anterolateral or&#xD;
      anteromedial in flexion knee position. Aseptic and antiseptic in site of injection use&#xD;
      povidone iodine 3 times, then swab by alcohol. Local anesthetic by lidocaine 1% is injected&#xD;
      subcutaneously.&#xD;
&#xD;
      Monitoring at the site of injection encompass allergic reaction, pain, and swelling. Patients&#xD;
      are approached to be followed up every three months, in 1st ,3rd ,6th ,12th month, for&#xD;
      clinical examination, VAS, IKDC and WOMAC Score. Cartigram MRI are evaluated every six month,&#xD;
      in 6th and 12th month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2015</start_date>
  <completion_date type="Anticipated">May 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2019</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cartilage T2 map score</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IKDC score</measure>
    <time_frame>3 months</time_frame>
    <description>Subjective assessment of knee function using the International Knee Documentation Committee Subjective Knee Evaluation form.&#xD;
Scale ranges from 1 to 100, higher value indicates higher function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>WOMAC score</measure>
    <time_frame>3 months</time_frame>
    <description>Subjective assessment of knee function using the the Western Ontario and McMaster Universities Osteoarthritis Index.&#xD;
Scale ranges from 100% to 1%, lower value indicates higher function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS score</measure>
    <time_frame>3 months</time_frame>
    <description>VAS score is used to assess knee pain experienced by subjects.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">9</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyaluronic Acid</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention 1</arm_group_label>
    <arm_group_label>Intervention 2</arm_group_label>
    <arm_group_label>Intervention 3</arm_group_label>
    <other_name>Hyaluronan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Umbilical Cord Mesenchymal Stem Cell</intervention_name>
    <arm_group_label>Intervention 1</arm_group_label>
    <arm_group_label>Intervention 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Recombinant Human Somatropin</intervention_name>
    <arm_group_label>Intervention 1</arm_group_label>
    <arm_group_label>Intervention 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 30-80 years old&#xD;
&#xD;
          -  Kellgren-Lawrence grade I, II, and III, or KL grade III with corrective osteotomy&#xD;
             according to knee x-ray examination&#xD;
&#xD;
          -  Minimal VAS: 2&#xD;
&#xD;
          -  Unresponsive with pharmacological therapy&#xD;
&#xD;
          -  Signed the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Osteoarthritis KL grade IV&#xD;
&#xD;
          -  Secondary osteoarthritis due to trauma, infection, rheumatoid arthritis, congenital&#xD;
             diseases, autoimmune diseases&#xD;
&#xD;
          -  Hypersensitivity to hyaluronic acid&#xD;
&#xD;
          -  Malignancies (Previously or currently diagnosed)&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ismail H Dilogo, MD, PhD</last_name>
    <phone>+622144539917</phone>
    <email>ismailorthofkui@yahoo.co.id</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tri Kurniawati, BSc</last_name>
    <phone>+622144539917</phone>
    <email>selpuncarscm@yahoo.co.id</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Universitas Indonesia</name>
      <address>
        <city>Jakarta Pusat</city>
        <state>Jakarta</state>
        <zip>10430</zip>
        <country>Indonesia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tri Kurniawati, BSc</last_name>
      <phone>+622144539917</phone>
      <email>selpuncarscm@yahoo.co.id</email>
    </contact>
    <investigator>
      <last_name>Ismail H Dilogo, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <link>
    <url>http://emedicine.medscape.com/article/330487-overview</url>
    <description>Lozada, CJ. Et al. Osteoarthritis</description>
  </link>
  <link>
    <url>http://emedicine.medscape.com/article/2089136-overview</url>
    <description>Hamami, MB. Growth Hormone</description>
  </link>
  <link>
    <url>http://radiopaedia.org/articles/kellgren-and-lawrence-system-for-classification-of-osteoarthritis-of-knee</url>
    <description>12. Luijkx V, Pai V. Kellgren and Lawrence system for the classification of the osteoarthritis of the knee</description>
  </link>
  <link>
    <url>https://www.rheumatology.org/Practice/Clinical/Clinicianresearchers/Outcomes_Instrumentation/Western_Ontario_and_McMaster_Universities_Osteoarthritis_Index_%28WOMAC%29/</url>
    <description>Anonimous. WOMAC index</description>
  </link>
  <reference>
    <citation>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</citation>
  </reference>
  <reference>
    <citation>Singh A, Goel SC, Gupta KK, Kumar M, Arun GR, Patil H, Kumaraswamy V, Jha S. The role of stem cells in osteoarthritis: An experimental study in rabbits. Bone Joint Res. 2014 Feb 13;3(2):32-7. doi: 10.1302/2046-3758.32.2000187. Print 2014.</citation>
    <PMID>24526748</PMID>
  </reference>
  <reference>
    <citation>Tsai SY, Huang YC, Chueh LL, Yeh LS, Lin CS. Intra-articular transplantation of porcine adipose-derived stem cells for the treatment of canine osteoarthritis: A pilot study. World J Transplant. 2014 Sep 24;4(3):196-205. doi: 10.5500/wjt.v4.i3.196.</citation>
    <PMID>25346893</PMID>
  </reference>
  <reference>
    <citation>Kim SB, Kwon DR, Kwak H, Shin YB, Han HJ, Lee JH, Choi SH. Additive effects of intra-articular injection of growth hormone and hyaluronic acid in rabbit model of collagenase-induced osteoarthritis. J Korean Med Sci. 2010 May;25(5):776-80. doi: 10.3346/jkms.2010.25.5.776. Epub 2010 Apr 16.</citation>
    <PMID>20436717</PMID>
  </reference>
  <reference>
    <citation>Vangsness CT Jr, Farr J 2nd, Boyd J, Dellaero DT, Mills CR, LeRoux-Williams M. Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study. J Bone Joint Surg Am. 2014 Jan 15;96(2):90-8. doi: 10.2106/JBJS.M.00058.</citation>
    <PMID>24430407</PMID>
  </reference>
  <reference>
    <citation>Dart AJ, Little CB, Hughes CE, Chu O, Dowling BA, Hodgson DR, Rose RJ, Johnson KA. Recombinant equine growth hormone administration: effects on synovial fluid biomarkers and cartilage metabolism in horses. Equine Vet J. 2003 May;35(3):302-7. doi: 10.2746/042516403776148165.</citation>
    <PMID>12755435</PMID>
  </reference>
  <reference>
    <citation>White DK, Keysor JJ, Lavalley MP, Lewis CE, Torner JC, Nevitt MC, Felson DT. Clinically important improvement in function is common in people with or at high risk of knee OA: the MOST study. J Rheumatol. 2010 Jun;37(6):1244-51. doi: 10.3899/jrheum.090989. Epub 2010 Apr 15.</citation>
    <PMID>20395640</PMID>
  </reference>
  <reference>
    <citation>Raynauld JP, Torrance GW, Band PA, Goldsmith CH, Tugwell P, Walker V, Schultz M, Bellamy N; Canadian Knee OA Study Group. A prospective, randomized, pragmatic, health outcomes trial evaluating the incorporation of hylan G-F 20 into the treatment paradigm for patients with knee osteoarthritis (Part 1 of 2): clinical results. Osteoarthritis Cartilage. 2002 Jul;10(7):506-17. doi: 10.1053/joca.2002.0798.</citation>
    <PMID>12127830</PMID>
  </reference>
  <reference>
    <citation>Higgins LD, Taylor MK, Park D, Ghodadra N, Marchant M, Pietrobon R, Cook C; International Knee Documentation Committee. Reliability and validity of the International Knee Documentation Committee (IKDC) Subjective Knee Form. Joint Bone Spine. 2007 Dec;74(6):594-9. doi: 10.1016/j.jbspin.2007.01.036. Epub 2007 Aug 6.</citation>
    <PMID>17888709</PMID>
  </reference>
  <reference>
    <citation>Sinusas K. Osteoarthritis: diagnosis and treatment. Am Fam Physician. 2012 Jan 1;85(1):49-56. Erratum In: Am Fam Physician. 2012 Nov 15;86(10):893.</citation>
    <PMID>22230308</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 2, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 21, 2019</last_update_submitted>
  <last_update_submitted_qc>January 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indonesia University</investigator_affiliation>
    <investigator_full_name>Ismail Hadisoebroto Dilogo</investigator_full_name>
    <investigator_title>Consultant, Department of Orthopaedics and Traumatology</investigator_title>
  </responsible_party>
  <keyword>Osteoarthritis</keyword>
  <keyword>Mesenchymal Stem Cells</keyword>
  <keyword>Umbilical Cord</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Name Gender Contact Address Sign up</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03800810
org study id: ISMMSCOA
nct id: NCT03800810
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Cartilage T2 map score
time frame: 6 months
description: 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.
measure: IKDC score
time frame: 3 months
description: 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.
measure: WOMAC score
time frame: 3 months
description: 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.
measure: VAS score
time frame: 3 months
description: VAS score is used to assess knee pain experienced by subjects.
arm group label: Control
arm group type: Experimental
description: 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)
arm group label: Intervention 1
arm group type: Experimental
description: 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)
arm group label: Intervention 2
arm group type: Experimental
description: 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)
arm group label: Intervention 3
arm group type: Experimental
description: 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)
intervention type: Drug
intervention name: Hyaluronic Acid
arm group label: Control
arm group label: Intervention 1
arm group label: Intervention 2
arm group label: Intervention 3
other name: Hyaluronan
intervention type: Biological
intervention name: Umbilical Cord Mesenchymal Stem Cell
arm group label: Intervention 1
arm group label: Intervention 2
intervention type: Biological
intervention name: Recombinant Human Somatropin
arm group label: Intervention 1
arm group label: Intervention 3
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ismail H Dilogo, MD, PhD
phone: +622144539917
email: ismailorthofkui@yahoo.co.id
last name: Tri Kurniawati, BSc
phone: +622144539917
email: selpuncarscm@yahoo.co.id
facility: 
status: Recruiting
contact: 
investigator: 
country: Indonesia
url: http://emedicine.medscape.com/article/330487-overview
description: Lozada, CJ. Et al. Osteoarthritis
url: http://emedicine.medscape.com/article/2089136-overview
description: Hamami, MB. Growth Hormone
url: http://radiopaedia.org/articles/kellgren-and-lawrence-system-for-classification-of-osteoarthritis-of-knee
description: 12. Luijkx V, Pai V. Kellgren and Lawrence system for the classification of the osteoarthritis of the knee
url: https://www.rheumatology.org/Practice/Clinical/Clinicianresearchers/Outcomes_Instrumentation/Western_Ontario_and_McMaster_Universities_Osteoarthritis_Index_%28WOMAC%29/
description: Anonimous. WOMAC index
citation: 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
citation: Singh A, Goel SC, Gupta KK, Kumar M, Arun GR, Patil H, Kumaraswamy V, Jha S. The role of stem cells in osteoarthritis: An experimental study in rabbits. Bone Joint Res. 2014 Feb 13;3(2):32-7. doi: 10.1302/2046-3758.32.2000187. Print 2014.
PMID: 24526748
citation: Tsai SY, Huang YC, Chueh LL, Yeh LS, Lin CS. Intra-articular transplantation of porcine adipose-derived stem cells for the treatment of canine osteoarthritis: A pilot study. World J Transplant. 2014 Sep 24;4(3):196-205. doi: 10.5500/wjt.v4.i3.196.
PMID: 25346893
citation: Kim SB, Kwon DR, Kwak H, Shin YB, Han HJ, Lee JH, Choi SH. Additive effects of intra-articular injection of growth hormone and hyaluronic acid in rabbit model of collagenase-induced osteoarthritis. J Korean Med Sci. 2010 May;25(5):776-80. doi: 10.3346/jkms.2010.25.5.776. Epub 2010 Apr 16.
PMID: 20436717
citation: Vangsness CT Jr, Farr J 2nd, Boyd J, Dellaero DT, Mills CR, LeRoux-Williams M. Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study. J Bone Joint Surg Am. 2014 Jan 15;96(2):90-8. doi: 10.2106/JBJS.M.00058.
PMID: 24430407
citation: Dart AJ, Little CB, Hughes CE, Chu O, Dowling BA, Hodgson DR, Rose RJ, Johnson KA. Recombinant equine growth hormone administration: effects on synovial fluid biomarkers and cartilage metabolism in horses. Equine Vet J. 2003 May;35(3):302-7. doi: 10.2746/042516403776148165.
PMID: 12755435
citation: White DK, Keysor JJ, Lavalley MP, Lewis CE, Torner JC, Nevitt MC, Felson DT. Clinically important improvement in function is common in people with or at high risk of knee OA: the MOST study. J Rheumatol. 2010 Jun;37(6):1244-51. doi: 10.3899/jrheum.090989. Epub 2010 Apr 15.
PMID: 20395640
citation: Raynauld JP, Torrance GW, Band PA, Goldsmith CH, Tugwell P, Walker V, Schultz M, Bellamy N; Canadian Knee OA Study Group. A prospective, randomized, pragmatic, health outcomes trial evaluating the incorporation of hylan G-F 20 into the treatment paradigm for patients with knee osteoarthritis (Part 1 of 2): clinical results. Osteoarthritis Cartilage. 2002 Jul;10(7):506-17. doi: 10.1053/joca.2002.0798.
PMID: 12127830
citation: Higgins LD, Taylor MK, Park D, Ghodadra N, Marchant M, Pietrobon R, Cook C; International Knee Documentation Committee. Reliability and validity of the International Knee Documentation Committee (IKDC) Subjective Knee Form. Joint Bone Spine. 2007 Dec;74(6):594-9. doi: 10.1016/j.jbspin.2007.01.036. Epub 2007 Aug 6.
PMID: 17888709
citation: Sinusas K. Osteoarthritis: diagnosis and treatment. Am Fam Physician. 2012 Jan 1;85(1):49-56. Erratum In: Am Fam Physician. 2012 Nov 15;86(10):893.
PMID: 22230308
responsible party type: Principal Investigator
investigator affiliation: Indonesia University
investigator full name: Ismail Hadisoebroto Dilogo
investigator title: Consultant, Department of Orthopaedics and Traumatology
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Hyaluronic Acid
sharing ipd: Yes
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