<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/NCT03308006</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 2018-04</org_study_id>
    <nct_id>NCT03308006</nct_id>
  </id_info>
  <brief_title>Knee Osteoarthritis Treatment With Adipose-derived Stem Cells: Phase II Clinical Trial</brief_title>
  <official_title>Knee Osteoarthritis Treatment With Adipose-derived Stem Cells: Phase II Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Faisal Specialist Hospital &amp; Research Centre, Jeddah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Faisal Specialist Hospital &amp; Research Centre, Jeddah</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In 1990, the prevalence of osteoarthritis of the hip or knee was very low 3.5% in Saudi&#xD;
      Arabia, it increased to 53.3% and 60.9% in male in female patients respectively in 2002. The&#xD;
      existing management of OA is conservative and pharmacological management aiming to relief&#xD;
      symptoms of osteoarthritis and improves joint function. Results of a Meta-Analysis showed&#xD;
      that mesenchymal stem cell is effectiveness and safe to treat knee osteoarthritis. In 1990,&#xD;
      the prevalence of osteoarthritis of the hip or knee was very low 3.5% in the Kingdom of Saudi&#xD;
      Arabia and it increased to 53.3% and 60.9% in male in female patients respectively in 2002.&#xD;
      Results of a Meta-Analysis showed that mesenchymal stem cell is effectiveness and safe to&#xD;
      treat knee osteoarthritis. This study will be a single center phase II-one arm clinical&#xD;
      trial. It will be conducted at KF SH&amp;RC-Jeddah. 18 participants will be recruited from&#xD;
      orthopedic clinics. Participate will be evaluated before inclusion in the study. Participants&#xD;
      will be exposed to e abdominal liposuction procedure under local anesthesia for stem cells&#xD;
      harvesting. Stem cells will be separated from fat cells in the adipose tissue then activated&#xD;
      in Tissue Culture Lab at Research Center- Jeddah. The activated stem cells will be injected&#xD;
      into the knee joint via 22G spinal needle. The intra-articular stem cells injections will be&#xD;
      performed under Ultrasound guidance at the theater under spinal anesthesia. Each patient will&#xD;
      receive 1.0× 108 stem cells in 3 mL of normal saline&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      STUDY DESIGN, LOCATION AND PATIENTS This study will be a single center phase II one arm&#xD;
      clinical trial. It will be conducted at King Faisal Specialist Hospital &amp;Research Center&#xD;
      (Gen. Org.)-Jeddah. The decided sample size will be between 12 to 18 participants.&#xD;
      Participants will be recruited from orthopedic clinics. Each patient will receive 1.0× 108&#xD;
      stem cells in 3 mL of normal saline.&#xD;
&#xD;
      All patients who are potentially eligible to be included in the study, and agreed to&#xD;
      participate will be evaluated medically. Baseline assessment will involve complete general&#xD;
      and orthopedic physical examination. Complete laboratory investigations and radiological&#xD;
      investigations including diagnostic MRI of the knee to confirm the diagnosis will performed&#xD;
      to each patient.&#xD;
&#xD;
      Inclusion Criteria In this study, participants will be considered as having Knee&#xD;
      osteoarthritis if the patient's x-rays showed grade 2 or higher Kellgren and Lawrence scale.&#xD;
      He/she will be potentially eligible to be included in the study if his/her age is between 45&#xD;
      and 65 years and diagnosed by orthopedic consultant as having idiopathic osteoarthritis of&#xD;
      the knee and had an average pain intensity of grade 4 or more on a 10-point visual analog for&#xD;
      at least one year.&#xD;
&#xD;
      Exclusion Criteria Patient will be excluded if she/he had history of chronic rheumatic or&#xD;
      inflammatory diseases, poorly controlled diabetes, or currently on OA treatments.&#xD;
&#xD;
      Data collection Potentially eligible participants will receive verbal and formal written&#xD;
      information about the study and invited to participate. Eligible participants who provide&#xD;
      written consent to participate will be asked to fill out a well known reliable and valid&#xD;
      Musculoskeletal Pain Questionnaire (The Orebro Musculoskeletal Pain Questionnaire).&#xD;
&#xD;
      Procedures The procedure of KOA stem cell therapy will be done in four stages, harvesting,&#xD;
      separation, activation, and treatment stage. In summary, Participants in this phase II one&#xD;
      arm clinical trial will be exposed to simple abdominal liposuction procedure under local&#xD;
      anesthesia for stem cells harvesting. Stem cells will be separated from fat cells in the&#xD;
      adipose tissue then activated in Tissue Culture Lab at Research Center- JEDDAH after that the&#xD;
      activated stem cells will be injected into the knee joint via 22G spinal needle. The&#xD;
      intra-articular stem cells injections will be performed under Ultrasound guidance at the&#xD;
      theater under spinal anesthesia.&#xD;
&#xD;
      Personnel Simple abdominal Liposuction will be performed by accredited plastic surgeon.&#xD;
      Qualified scientist and qualified and trained technicians will perform stem cells separation&#xD;
      and activation under good manufacturing practice conditions, and orthopedic surgeon will&#xD;
      perform intra-articular stem cells injections.&#xD;
&#xD;
      Outcome Measures Participants will be followed for one year after the date of stem cells knee&#xD;
      joint injection and monitored and evaluated for serious adverse events, clinical outcomes,&#xD;
      the size, depth and histological assessment of regenerated cartilage.&#xD;
&#xD;
      Statistical Analysis Categorical data will be summarized by measuring the frequency and&#xD;
      percentage and measures of central tendency and dispersions will be used summarize numeric&#xD;
      data. Paired t test and Wilcoxon signed rank test will be used to compare the changes from&#xD;
      baseline in parametric and non-parametric data respectively. The analysis will be performed&#xD;
      using SPSS version 16&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">April 12, 2023</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Regenerated cartilage</measure>
    <time_frame>One year</time_frame>
    <description>Histological assessment of regenerated cartilage</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Stem cells therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Stem cells</intervention_name>
    <description>Participants will be exposed to e abdominal liposuction procedure under local anesthesia for stem cells harvesting. Stem cells will be separated from fat cells in the adipose tissue then activated in Tissue Culture Lab at Research Center- Jeddah. The activated stem cells will be injected into the knee joint via 22G spinal needle. The intra-articular stem cells injections will be performed under Ultrasound guidance at the theater under spinal anesthesia. Each patient will receive 1.0× 108 stem cells in 3 mL of normal saline.</description>
    <arm_group_label>Stem cells therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 45 and 65.&#xD;
&#xD;
          -  Participants having Knee osteoarthritis grade 2 or higher &quot;Kellgren and Lawrence&#xD;
             scale&quot;&#xD;
&#xD;
          -  Participants had an average pain intensity of grade 4 or more on a 10-point visual&#xD;
             analog for at least one year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with history of rheumatic or chronic inflammatory diseases&#xD;
&#xD;
          -  Patient poorly controlled diabetes,&#xD;
&#xD;
          -  Patient who currently on OA treatment such as corticosteroids, chondroitin sulfate,&#xD;
             glucosamine or hyaluronic acid.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>. Zainullah Al Shareef, MD</last_name>
    <role>Study Chair</role>
    <affiliation>King Faisal Specialist Hospital &amp; Research Cener -Jeddah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>King Faisal Sepcialist Hospital and Research Center</name>
      <address>
        <city>Jeddah</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>No</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/NCT03308006
org study id: IRB 2018-04
nct id: NCT03308006
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In 1990, the prevalence of osteoarthritis of the hip or knee was very low 3.5% in Saudi
      Arabia, it increased to 53.3% and 60.9% in male in female patients respectively in 2002. The
      existing management of OA is conservative and pharmacological management aiming to relief
      symptoms of osteoarthritis and improves joint function. Results of a Meta-Analysis showed
      that mesenchymal stem cell is effectiveness and safe to treat knee osteoarthritis. In 1990,
      the prevalence of osteoarthritis of the hip or knee was very low 3.5% in the Kingdom of Saudi
      Arabia and it increased to 53.3% and 60.9% in male in female patients respectively in 2002.
      Results of a Meta-Analysis showed that mesenchymal stem cell is effectiveness and safe to
      treat knee osteoarthritis. This study will be a single center phase II-one arm clinical
      trial. It will be conducted at KF SH&RC-Jeddah. 18 participants will be recruited from
      orthopedic clinics. Participate will be evaluated before inclusion in the study. Participants
      will be exposed to e abdominal liposuction procedure under local anesthesia for stem cells
      harvesting. Stem cells will be separated from fat cells in the adipose tissue then activated
      in Tissue Culture Lab at Research Center- Jeddah. The activated stem cells will be injected
      into the knee joint via 22G spinal needle. The intra-articular stem cells injections will be
      performed under Ultrasound guidance at the theater under spinal anesthesia. Each patient will
      receive 1.0× 108 stem cells in 3 mL of normal saline
STUDY DESIGN, LOCATION AND PATIENTS This study will be a single center phase II one arm
      clinical trial. It will be conducted at King Faisal Specialist Hospital &Research Center
      (Gen. Org.)-Jeddah. The decided sample size will be between 12 to 18 participants.
      Participants will be recruited from orthopedic clinics. Each patient will receive 1.0× 108
      stem cells in 3 mL of normal saline.

      All patients who are potentially eligible to be included in the study, and agreed to
      participate will be evaluated medically. Baseline assessment will involve complete general
      and orthopedic physical examination. Complete laboratory investigations and radiological
      investigations including diagnostic MRI of the knee to confirm the diagnosis will performed
      to each patient.

      Inclusion Criteria In this study, participants will be considered as having Knee
      osteoarthritis if the patient's x-rays showed grade 2 or higher Kellgren and Lawrence scale.
      He/she will be potentially eligible to be included in the study if his/her age is between 45
      and 65 years and diagnosed by orthopedic consultant as having idiopathic osteoarthritis of
      the knee and had an average pain intensity of grade 4 or more on a 10-point visual analog for
      at least one year.

      Exclusion Criteria Patient will be excluded if she/he had history of chronic rheumatic or
      inflammatory diseases, poorly controlled diabetes, or currently on OA treatments.

      Data collection Potentially eligible participants will receive verbal and formal written
      information about the study and invited to participate. Eligible participants who provide
      written consent to participate will be asked to fill out a well known reliable and valid
      Musculoskeletal Pain Questionnaire (The Orebro Musculoskeletal Pain Questionnaire).

      Procedures The procedure of KOA stem cell therapy will be done in four stages, harvesting,
      separation, activation, and treatment stage. In summary, Participants in this phase II one
      arm clinical trial will be exposed to simple abdominal liposuction procedure under local
      anesthesia for stem cells harvesting. Stem cells will be separated from fat cells in the
      adipose tissue then activated in Tissue Culture Lab at Research Center- JEDDAH after that the
      activated stem cells will be injected into the knee joint via 22G spinal needle. The
      intra-articular stem cells injections will be performed under Ultrasound guidance at the
      theater under spinal anesthesia.

      Personnel Simple abdominal Liposuction will be performed by accredited plastic surgeon.
      Qualified scientist and qualified and trained technicians will perform stem cells separation
      and activation under good manufacturing practice conditions, and orthopedic surgeon will
      perform intra-articular stem cells injections.

      Outcome Measures Participants will be followed for one year after the date of stem cells knee
      joint injection and monitored and evaluated for serious adverse events, clinical outcomes,
      the size, depth and histological assessment of regenerated cartilage.

      Statistical Analysis Categorical data will be summarized by measuring the frequency and
      percentage and measures of central tendency and dispersions will be used summarize numeric
      data. Paired t test and Wilcoxon signed rank test will be used to compare the changes from
      baseline in parametric and non-parametric data respectively. The analysis will be performed
      using SPSS version 16
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Regenerated cartilage
time frame: One year
description: Histological assessment of regenerated cartilage
arm group label: Stem cells therapy
arm group type: Experimental
intervention type: Biological
intervention name: Stem cells
description: Participants will be exposed to e abdominal liposuction procedure under local anesthesia for stem cells harvesting. Stem cells will be separated from fat cells in the adipose tissue then activated in Tissue Culture Lab at Research Center- Jeddah. The activated stem cells will be injected into the knee joint via 22G spinal needle. The intra-articular stem cells injections will be performed under Ultrasound guidance at the theater under spinal anesthesia. Each patient will receive 1.0× 108 stem cells in 3 mL of normal saline.
arm group label: Stem cells therapy
criteria: 
gender: All
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: No
last name: . Zainullah Al Shareef, MD
role: Study Chair
affiliation: King Faisal Specialist Hospital & Research Cener -Jeddah
facility: 
country: Saudi Arabia
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No