Effect of Mesenchymal Stem Cells in Primary Knee Osteoarthritis

Osteoarthritis Knee Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05783154
• Other study ID #: BSMMU/2022/8897
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 16, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2023
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: Moshiur Rahman Khasru, MBBS, FCPS
• Phone: +8801716045646
• Email: drkhasrupmr[@]bsmmu.edu.bd
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: September 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Knee
• Osteoarthritis, Knee

Intervention

Biological:
• Autologous Adipose Tissue-Derived Mesenchymal Stem Cell
After cleaning the knee with 10% povidone-iodine (Povidep10% solution, manufactured by Jayson Pharmaceuticals limited, Bangladesh) and draping it in a sterile manner, the injection site will be anesthetized with 0.5% bupivacaine (Inj. Bupi Heavy 0.5%, Manufactured by Popular Pharmaceuticals limited, Bangladesh) superficially outside of joint capsule. Within one hour of preparation, the autologous AT-MSC will be injected into each knee joint through medial tibio-femoral compartment in group -I using a 38-mm 18- gauge needle

Locations

Country	Name	City	State
Bangladesh	Bangabandhu Sheikh Mujib Medical University	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Articular Cartilage Defect	Cartilage defect will be evaluated by MRI Osteoarthritis Knee score (MOAKS). MOAKS will be considered to describe the cartilage defect. In MOAKS the knee is divided into 14 articular sub-regions for scoring articular cartilage and Bone Marrow Lesions (BML) [0-100%] where higher score indicates more bone-marrow-lesion and the BML grades are as follows: grade 0= none, grade 1 <33%, grade 2= 33-66% and grade 3 >66%.	Cartilage defect will be measure before and after treatment at the month 6 and 12.
Primary	Changes in Femoral Cartilage thickness	Femoral cartilage thickness will be measured at the three level specifically medial condyle, lateral condyle and intercondylar notch using high frequency ultrasound (Machine Model: Chison Qbit-7, Transducer: 15 mega hertz (MHz) Linear). Mean value of the three measurement will be considered for mean femoral cartilage thickness (0-4 mm).	Mean femoral cartilage will be measured before and after treatment at the month 6, and12.
Primary	Changes in the Pain Intensity	Pain intensity of the knee joint will be evaluated by visual analogue scale (VAS) ranges between 0 to 10 (0-10 cm scale) where score 0 indicate 'no pain' and 10 indicates 'worst pain'.	Pain intensity will be measured before and after treatment at the month 1, 3, 6, and12
Primary	Changes in Physical functioning	Physical functioning will be measured by The Western Ontario and McMaster Universities Arthritis Index (WOMAC) scale. WOMAC has 17 item Physical Function measure where each item score ranges between 0 to 4, and total physical function score ranges between 0-68. The higher score indicates worse physical function of the joint examined.	Physical functioning will be measured before and after treatment at the month 1, 3, 6, and 12
Secondary	Any Complications arises	Any immediate and late complications will be documents up to 12 months after the treatment.; All the participants will be examined for any complications during each scheduled follow-up at the month 1, 3, 6, and 12 after treatment.; Moreover, all the participants will be asked to communicate with the investigator team for any complication/issue arises at any time within 12 months of the treatment by dedicated mobile phone number, which will be given to all the participants.	At the month 1, 3, 6, and 12 after treatment as well as at anytime within 12 months of the treatment (if required)