Clinical trial NCT05280002: Adipose-tissue-derived Total-Stromal-cells (TOST) Therapy in Knee Osteoarthritis
Official title: Outcomes of Single Intra-articular Injection of Adipose-tissue-derived Total-Stromal-cells (TOST) Therapy in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis Knees
Keywords: Osteoarthritis, Adipose Tissue, TOST, Stem Cell
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
Collaborators: name: Dhaka Medical College
First posted: 2022-03-15
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Primary KOA with KL-grade II and III radiological changes

Exclusion Criteria:

* KOA received IA steroid, viscosupplementation, or PRP injection or undergone knee surgery within the last six months.
* Patients with septic and tubercular arthritis, post-traumatic hemarthrosis, unstable knee joint due to anterior cruciate ligament (ACL) injury, malignancy, autoinflammatory arthritis (gout), inflammatory disease (rheumatoid arthritis, psoriatic arthritis, reactive, and ankylosing spondylitis), and charcot arthropathy.
* Patients with local eczematous skin and skin infection

Primary outcomes:
measure: Changes in pain intensity
timeFrame: Before treatment and after treatment at week 4, 12, and 24
measure: Changes in Physical functioning of knee joints.
timeFrame: Before treatment and after treatment at week 4, 12, and 24
measure: Changes in femoral cartilage thickness
timeFrame: Baseline and 24 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Bangabandhu Sheikh Mujib Medical University
Study officials:
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Moshiur Rahman Khasru, MBBS, FCPS
role: PRINCIPAL_INVESTIGATOR
References: