<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/NCT03024801</url>
  </required_header>
  <id_info>
    <org_study_id>ChinaPLAGH_003</org_study_id>
    <nct_id>NCT03024801</nct_id>
  </id_info>
  <brief_title>Effectiveness of Autologous Platelet-rich Plasma on Knee Cartilage Injury</brief_title>
  <official_title>Effectiveness of Autologous Platelet-rich Plasma on Knee Cartilage Injury: a Randomized, Controlled, Open-label Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese PLA General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To analyze the effectiveness of intra-articular injection of autologous PRP on knee cartilage&#xD;
      repair and evaluating functional recovery of the knee joint in knee cartilage injury&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent studies have shown that platelets, which contain a large number of cytokines and&#xD;
      growth factors, can be beneficial in inflammatory response and postoperative bleeding,&#xD;
      infection, bone formation, injury, muscle strain, and soft tissue healing. Platelets release&#xD;
      a plethora of biologically active proteins to aggregate macrophages, mesenchymal stem cells&#xD;
      (MSCs) and osteoblasts, thereby promoting degradation and clearing necrotic tissue, thus&#xD;
      further activating wound healing. In fact, platelet-rich plasma (PRP) is now used clinically&#xD;
      to promote cartilage repair.&#xD;
&#xD;
      By retrieving the Web of Science, a study by Havva et al. reported the clinical use of&#xD;
      autologous PRP in 82 patients with advanced knee osteoarthritis with good outcomes. However,&#xD;
      the clinical applications of this treatment have not been adequately investigated in&#xD;
      randomized controlled trials. Given this, additional studies on the exact efficacy of this&#xD;
      treatment are indispensible.&#xD;
&#xD;
      Three similar trial protocols to the current trial include 'Treatment of Osteoarthritis by&#xD;
      Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells With Platelet Rich Plasma&#xD;
      (NCT02365142)', 'PRP vs HA Intra-articular Knee Injections for Cartilage Defects&#xD;
      (NCT02012530)', and 'Mesenchymal Stem Cells Enhanced With PRP Versus PRP In OA Knee&#xD;
      (MSCPRPOAK) (NCT01985633)'. In these trial protocols, knee injury extent and treatment&#xD;
      success were assessed by Osteoarthritis Score, Western Ontario and McMaster Universities&#xD;
      Osteoarthritis Index (WOMAC) and Visual Analog Scale (VAS) score as outcome measures.&#xD;
      However, there are several differences in the inclusion criteria and randomization of these&#xD;
      trials in comparison with the current trial protocol.&#xD;
&#xD;
      Since autologous PRP predominantly functions to relieve pain and inhibit inflammatory&#xD;
      responses, clinical injection of autologous PRP for cartilage injury can stimulate&#xD;
      chondrocyte growth and matrix metabolism. Existing evidence has shown that autologous PRP can&#xD;
      increase type II collagen production and reduce apoptosis in chondrocytes when combined with&#xD;
      autologous bone marrow-MSCs. Furthermore, PRP can improve cartilage degeneration and inhibit&#xD;
      the development of osteoarthritis (OA) when combined with hydrogel microspheres. Accordingly,&#xD;
      the clinical use of autologous PRP can alleviate the symptoms of OA, promote recovery of&#xD;
      motor function, and ultimately improve patient quality of life.&#xD;
&#xD;
      To date, the clinical use of low-dose autologous PRP has been reported to alleviate pain at&#xD;
      the injury site in the treatment of articular cartilage injury, and achieve cartilage repair&#xD;
      and proliferation by releasing growth factors that promote extracellular matrix synthesis and&#xD;
      vascular reconstruction. However, the clinical applications of autologous PRP have not been&#xD;
      systemically reported in randomized controlled clinical trials, leading to a lack of&#xD;
      objective evidence on its effectiveness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lysholm score</measure>
    <time_frame>at 3 months after final injection</time_frame>
    <description>To assess functional recovery of the knee joint. Lysholm score ranges from 0-100 with higher scores indicating better knee joint function. A score &lt;70 indicates damage to the knee joint function.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>2000 IKDC Subjective Knee Evaluation Form score</measure>
    <time_frame>at 3 months after final injection</time_frame>
    <description>To used for assessing functional recovery of the knee joint. Higher scores indicate better recovery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical rating scale score</measure>
    <time_frame>changes of month 1, month 2 and month 3 after initial injection, and month 3 after final injection</time_frame>
    <description>To assess pain relief of the knee joint. The numerical rating scale score ranges from 0-10, with a score of 0 indicating no pain and 10 indicating intense pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Cartilage Injury</condition>
  <arm_group>
    <arm_group_label>autologous platelet-rich plasma group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients with knee cartilage injury were randomized to the intra-articular injection of autologous platelet-rich plasma group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal saline group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients with knee cartilage injury were randomized to the normal saline group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>autologous platelet-rich plasma</intervention_name>
    <description>The patients with knee cartilage injury were randomized to the intra-articular injection of autologous platelet-rich plasma group.</description>
    <arm_group_label>autologous platelet-rich plasma group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>normal saline</intervention_name>
    <description>The patients with knee cartilage injury were randomized to the normal saline group.</description>
    <arm_group_label>normal saline group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Knee cartilage injury&#xD;
&#xD;
          -  Having normal and stable joint motion but no deformity&#xD;
&#xD;
          -  Focal cartilage defects confirmed by magnetic resonance imaging (MRI), Outerbridge&#xD;
             classification III/IV with a defect size &lt; 10 cm2 graded as Outerbridge II at maximum&#xD;
&#xD;
          -  Focal articular cartilage injury in the knee&#xD;
&#xD;
          -  14-55 years of age&#xD;
&#xD;
          -  Provision of signed informed consent to participate in the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poor general condition&#xD;
&#xD;
          -  Blood diseases&#xD;
&#xD;
          -  Use of local hormone treatment within 3 months before the trial&#xD;
&#xD;
          -  Bleeding tendency&#xD;
&#xD;
          -  Drug addiction, including anesthetic, alcohol and poison&#xD;
&#xD;
          -  Inflammatory arthropathy, including specific and non-specific arthritis and severe&#xD;
             osteoarthritis&#xD;
&#xD;
          -  Contagious viral infection&#xD;
&#xD;
          -  Metabolic diseases, such as gout and rheumatism&#xD;
&#xD;
          -  Pregnant or lactating, or planning to become pregnant within 1 year after the initial&#xD;
             registration&#xD;
&#xD;
          -  Unable to cooperate with rehabilitation therapy because of psychological/mental&#xD;
             disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Quanyi Guo, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese PLA Hospital, China</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>January 18, 2017</last_update_submitted>
  <last_update_submitted_qc>January 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Quanyi Guo</investigator_full_name>
    <investigator_title>Chief Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03024801
org study id: ChinaPLAGH_003
nct id: NCT03024801
lead sponsor: 
has dmc: Yes
To analyze the effectiveness of intra-articular injection of autologous PRP on knee cartilage
      repair and evaluating functional recovery of the knee joint in knee cartilage injury
      patients.
Recent studies have shown that platelets, which contain a large number of cytokines and
      growth factors, can be beneficial in inflammatory response and postoperative bleeding,
      infection, bone formation, injury, muscle strain, and soft tissue healing. Platelets release
      a plethora of biologically active proteins to aggregate macrophages, mesenchymal stem cells
      (MSCs) and osteoblasts, thereby promoting degradation and clearing necrotic tissue, thus
      further activating wound healing. In fact, platelet-rich plasma (PRP) is now used clinically
      to promote cartilage repair.

      By retrieving the Web of Science, a study by Havva et al. reported the clinical use of
      autologous PRP in 82 patients with advanced knee osteoarthritis with good outcomes. However,
      the clinical applications of this treatment have not been adequately investigated in
      randomized controlled trials. Given this, additional studies on the exact efficacy of this
      treatment are indispensible.

      Three similar trial protocols to the current trial include 'Treatment of Osteoarthritis by
      Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells With Platelet Rich Plasma
      (NCT02365142)', 'PRP vs HA Intra-articular Knee Injections for Cartilage Defects
      (NCT02012530)', and 'Mesenchymal Stem Cells Enhanced With PRP Versus PRP In OA Knee
      (MSCPRPOAK) (NCT01985633)'. In these trial protocols, knee injury extent and treatment
      success were assessed by Osteoarthritis Score, Western Ontario and McMaster Universities
      Osteoarthritis Index (WOMAC) and Visual Analog Scale (VAS) score as outcome measures.
      However, there are several differences in the inclusion criteria and randomization of these
      trials in comparison with the current trial protocol.

      Since autologous PRP predominantly functions to relieve pain and inhibit inflammatory
      responses, clinical injection of autologous PRP for cartilage injury can stimulate
      chondrocyte growth and matrix metabolism. Existing evidence has shown that autologous PRP can
      increase type II collagen production and reduce apoptosis in chondrocytes when combined with
      autologous bone marrow-MSCs. Furthermore, PRP can improve cartilage degeneration and inhibit
      the development of osteoarthritis (OA) when combined with hydrogel microspheres. Accordingly,
      the clinical use of autologous PRP can alleviate the symptoms of OA, promote recovery of
      motor function, and ultimately improve patient quality of life.

      To date, the clinical use of low-dose autologous PRP has been reported to alleviate pain at
      the injury site in the treatment of articular cartilage injury, and achieve cartilage repair
      and proliferation by releasing growth factors that promote extracellular matrix synthesis and
      vascular reconstruction. However, the clinical applications of autologous PRP have not been
      systemically reported in randomized controlled clinical trials, leading to a lack of
      objective evidence on its effectiveness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Lysholm score
time frame: at 3 months after final injection
description: To assess functional recovery of the knee joint. Lysholm score ranges from 0-100 with higher scores indicating better knee joint function. A score <70 indicates damage to the knee joint function.
measure: 2000 IKDC Subjective Knee Evaluation Form score
time frame: at 3 months after final injection
description: To used for assessing functional recovery of the knee joint. Higher scores indicate better recovery.
measure: Numerical rating scale score
time frame: changes of month 1, month 2 and month 3 after initial injection, and month 3 after final injection
description: To assess pain relief of the knee joint. The numerical rating scale score ranges from 0-10, with a score of 0 indicating no pain and 10 indicating intense pain.
arm group label: autologous platelet-rich plasma group
arm group type: Experimental
description: The patients with knee cartilage injury were randomized to the intra-articular injection of autologous platelet-rich plasma group.
arm group label: normal saline group
arm group type: Experimental
description: The patients with knee cartilage injury were randomized to the normal saline group.
intervention type: Drug
intervention name: autologous platelet-rich plasma
description: The patients with knee cartilage injury were randomized to the intra-articular injection of autologous platelet-rich plasma group.
arm group label: autologous platelet-rich plasma group
intervention type: Drug
intervention name: normal saline
description: The patients with knee cartilage injury were randomized to the normal saline group.
arm group label: normal saline group
criteria: 
gender: All
minimum age: 14 Years
maximum age: 55 Years
healthy volunteers: No
last name: Quanyi Guo, Ph.D
role: Principal Investigator
affiliation: Chinese PLA Hospital, China
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Quanyi Guo
investigator title: Chief Physician
mesh term: Wounds and Injuries
sharing ipd: Undecided