Clinical trial NCT05783154: Effect of Mesenchymal Stem Cells in Primary Knee Osteoarthritis
Official title: Effect of Autologous Adipose Tissue-derived Mesenchymal Stem Cells (AT-MSCs) Therapy in Cartilage Regeneration Among Individuals With Primary Knee Osteoarthritis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Osteoarthritis Knee
Keywords: Osteoarthritis
Pain
Mesenchymal Stem Cell Therapy
Physical function
Outcome, Effectiveness
Disability
Quality of Life
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 84
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoarthritis (OA) is the most prevalent chronic joint disorder worldwide and is associated with significant pain and disability. Incidence and prevalence of osteoarthritis rise with increasing age. The prevalence of OA knee in Bangladesh seems to be higher due to poor working conditions, heavy physical labor, and occupational injuries which increase in the future. This will ultimately create a higher clinical and socioeconomic burden on the population and national economy. The course of the disease varies but is often progressive. OA of the knee is one of the common self-reported musculoskeletal pain conditions causing patients to visit the Physical Medicine and Rehabilitation (PM\&R) department, at BSMMU. The primary objectives of knee OA treatment focus on pain reduction, and joint mobility improvement, as well as the reduction of disease progression and preserving patients' independence and quality of life. Current treatments aim at alleviating these symptoms by several different methods: Non-pharmacological treatments, Pharmacological treatments, and Invasive interventions. Mesenchymal stem cells (MSCs) therapies for knee osteoarthritis are being investigated in various corners of the world. Both positive and negative findings were observed in that research. Although, the effectiveness of MSCs in KOA is not yet well known. Some studies found MSCs effective, and safe in KOA, and it has the potential to regenerate/heal degraded joint cartilage. MSCs can differentiate into cartilage tissue. Furthermore, MSCs have been shown to have paracrine anti-inflammatory and immunomodulatory effects by producing different growth factors and cytokines. This therapeutics option is under investigation to date. The objective of this trial is to find the effectiveness, safety, and dose difference of adipose tissue-derived stem cells (AT-MSCs) therapy for the treatment of knee osteoarthritis (KOA).

But in fact, there is no published data about the effectiveness of autologous adipose tissue-derived mesenchymal stem cells injection on pain, joint functioning, and femoral cartilage thickness in the management of knee osteoarthritis in Bangladesh. Henceforth, this trial will generate new knowledge about the effectiveness, safety, and appropriate dose of AT-MSCs for KOA. So this research will be helpful to generate evidence-based information for an effective treatment option for the management of KOA.


Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis of the target knee refractory to conventional treatment only.
* Age between 40-70 years.
* All the genders.
* Participant with knee pain who fulfill 2016 revised American College of Rheumatology (ACR) criteria for OA knee
* The Kellgren and Lawrence Grade ≥2 patients.
* Pain score \>3 on Visual analog scale \[VAS\], (0-10 cm scale).

Exclusion Criteria:

* Previous diagnosis of poly-articular disease
* Severe mechanical extra-articular deformation (\>15° varus/15° valgus)
* Systemic auto-immune rheumatic disease
* Arthroscopy or intra-articular infiltration in the last 6 months
* Chronic treatment with Immunosuppressive or anticoagulant drugs
* Corticosteroids treatment in the 3 last months
* Non-steroidal anti-inflammatory drugs therapy in the last 15 days
* Poorly controlled Diabetes mellitus, blood dyscrasias
* Septic or tubercular arthritis
* Recent trauma, fracture, and unstable knee joint

Primary outcomes:
measure: Changes in the Articular Cartilage Defect
timeFrame: Cartilage defect will be measure before and after treatment at the month 6 and 12.
measure: Changes in Femoral Cartilage thickness
timeFrame: Mean femoral cartilage will be measured before and after treatment at the month 6, and12.
measure: Changes in the Pain Intensity
timeFrame: Pain intensity will be measured before and after treatment at the month 1, 3, 6, and12
measure: Changes in Physical functioning
timeFrame: Physical functioning will be measured before and after treatment at the month 1, 3, 6, and 12
Secondary outcomes:
measure: Any Complications arises
timeFrame: At the month 1, 3, 6, and 12 after treatment as well as at anytime within 12 months of the treatment (if required)
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: