Adipose-tissue-derived Total-Stromal-cells (TOST) Therapy in Knee Osteoarthritis
Condition: Osteoarthritis Knees
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      In this phase II Randomized Clinical Trial (RCT), impacts of a single Intra-articular
      injection of autologous adipose tissue derive total-stromal-cells (TOST) on knee pain,
      physical function, stiffness, and cartilage thickness assessed and compared changes before
      and after intervention.

      Individuals with knee osteoarthritis (KOA) diagnosed by using the American College of
      Rheumatology (ACR) criteria for Osteoarthritis knee were included in the study.
      Kellgren-Lawrence (KL) radiological scores were used to define radiological changes and
      high-frequency musculoskeletal ultrasonogram (MSUS) was used to measure cartilage thickness.
    

Detailed description: 
      A phase II randomized clinical trial (RCT) was performed with primary Knee osteoarthritis
      (KOA) attended in the department of physical medicine and rehabilitation, BSMMU, between
      January 2018 and December 2021. Approval was obtained from the institutional review board of
      BSMMU for this clinical trial (Reference No: BSMMU/2018/25, dated 01/01/2018). Impacts of a
      single intra-articular (IA) injection of autologous adipose tissue derived
      total-stromal-cells (TOST) containing mesenchymal stem cells on pain, physical function,
      stiffness, and cartilage thickness assessed and compared before and after intervention.
      Patients satisfied the American College of Rheumatology (ACR) criteria for osteoarthritis
      (OA) knee included in the study. Kellgren-Lawrence (KL) radiological scores were used to
      define OA grade; however, high-frequency musculoskeletal ultrasonogram (MSUS) was used to
      measure cartilage thickness. There is no standard protocol to follow while assessing
      cartilage thickness; however, recent work of Podlipska and co-workers would be a worth
      consideration for using adipose tissue for cartilage regeneration. As medial tibio-femoral
      joint is the most commonly involved in KOA, here, we consider medial femoral cartilage
      thickness. The assessment used a commercially available ultrasound device (Samsung Accuvix,
      2010, origin- South Korea) with a 15 megahertz linear transducer ML6-15. The patient was
      positioned supine with the knee in full flexion. A proximal-distal probe sweeping over the
      anterior-central knee area, medial femoral articular cartilage imaged in an axial plane.
      Degenerated cartilage signified either loss of surface sharpness or increased inner
      echogenicity; local or total thinning of articular cartilage. The definitions for articular
      cartilage degeneration are as follows: Grade 0 - a monotonous anechoic band with sharp
      hyperechoic anterior and posterior interfaces, Grade 1 - loss of the average sharpness of
      cartilage interfaces and or increased echogenicity of the cartilage, Grade 2a - grade 1 plus
      thinning of articular cartilage less than 50%, Grade 2b - more than 50% but less than 100%
      thinning of articular cartilage, Grade 3 -100% local loss of the cartilage tissue.

      A total of thirty KOA was randomly divided into two groups - case and control. Both groups
      received conventional care for KOA (acetaminophen 1 gram thrice daily for 14 days, quadriceps
      strengthening exercises, aerobic exercise, mind-body, proprioception, mechanical diagnosis,
      and therapy (MDT) exercises, and activities of daily living (ADL) modifications4, 18-20.
      Fifteen received six milliliters (ml) single-dose of autologous adipose tissue derived
      total-stromal-cells (TOST) and 3 ml activated PRP). PRP was activated with 0.1 ml calcium
      gluconate per 0.9 ml of PRP (1:9 ratio). However, no orthobiological product was given in
      another fifteen participants.
    

Intervention name(s): Adipose Tissue derived Total-Stromal-Cells (TOST)
Intervention type(s): Biological
Intervention description(s): Single dose autologous aAdipose Tissue derived Total-Stromal-Cells (TOST) containing mesenchymal stem cell was injected in each knee of the participants having knee osteoarthritis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis, Adipose Tissue, TOST, Stem Cell