Effect of Mesenchymal Stem Cells in Primary Knee Osteoarthritis

NCT ID: NCT05783154

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-16
• Study Completion Date: 2024-09-30

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.

Conditions

Osteoarthritis Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group (Group-1)

In control group: 42 patients with primary KOA will receive standard conventional care including rehabilitation for knee osteoarthritis.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental Group (Group-2)

In the interventional group, another 42 patients with primary KOA will receive adipose tissue-derived mesenchymal stem cells (AT-MSCs) injection intra-articularly (Group-2). However, group-2 (Interventional group) will be subdivided into two sub-groups namely group-2a, and group-2b. A total of 21 Participants of group-2a will receive single doses of autologous adipose tissue-derived stem cell (AT-MSCs) and standard conservative care including rehabilitation for KOA. Whereas, group-2b, 21 respondents will receive two doses of autologous adipose tissue-derived stem cell (AT-MSCs) at 3 months intervals along with standard conservative care including rehabilitation for KOA.

Group Type: EXPERIMENTAL

Autologous Adipose Tissue-Derived Mesenchymal Stem Cell

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Moshiur Rahman Khasru

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moshiur Rahman Khasru, MBBS, FCPS

Role: PRINCIPAL_INVESTIGATOR

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Locations

Bangabandhu Sheikh Mujib Medical University

Dhaka, , Bangladesh

Site Status: RECRUITING

Countries

Bangladesh

Central Contacts

Moshiur Rahman Khasru, MBBS, FCPS

Role: CONTACT

drkhasrupmr@bsmmu.edu.bd

+8801716045646

Facility Contacts

Moshiur Rahman Khasru, MBBS, FCPS

Role: primary

drkhasrupmr@bsmmu.edu.bd

+8801716045646

Other Identifiers

BSMMU/2022/8897

Identifier Type: -

Identifier Source: org_study_id