Knee Osteoarthritis Treatment With Adipose-derived Stem Cells: Phase II Clinical Trial
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      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
    

Detailed description: 
      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
    

Intervention name(s): Stem cells
Intervention type(s): Biological
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment