NCT05783154

Effect of Mesenchymal Stem Cells in Primary Knee Osteoarthritis

Status unknown Phase 2, PHASE3 Last updated 24 March 2023

What this trial tests

Phase 2, PHASE3 trial testing Autologous Adipose Tissue-Derived Mesenchymal Stem Cell in Osteoarthritis Knee in 84 participants. Status unknown.

Timeline

16 September 2022

Primary endpoint
31 July 2024

30 September 2024

Quick facts

Lead sponsor	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	84
Start date	16 September 2022
Primary completion	31 July 2024
Estimated completion	30 September 2024
Sites	1 location across Bangladesh

Drugs / interventions tested

• Autologous Adipose Tissue-Derived Mesenchymal Stem Cell — full drug profile →

Conditions studied

• Osteoarthritis Knee — all drugs for Osteoarthritis Knee →

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Who can join

Adults 40 to 70, any sex, with Osteoarthritis Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cell-based therapy in the treatment of musculoskeletal diseases.
   Trapana J, Weinerman J, Lee D, Sedani A, et al · · 2024 · cited 18× · PMID 39226104 · DOI 10.1093/stcltm/szae049
2. Emerging Landscape of Mesenchymal Stem Cell Senescence Mechanisms and Implications on Therapeutic Strategies.
   Wang J, Zhang M, Wang H. · · 2024 · cited 13× · PMID 39144566 · DOI 10.1021/acsptsci.4c00284
3. Stem cell injections for osteoarthritis of the knee.
   Whittle SL, Johnston RV, McDonald S, Worthley D, et al · · 2025 · cited 11× · PMID 40169165 · DOI 10.1002/14651858.cd013342.pub2
4. Optimization strategies for mesenchymal stem cell-based analgesia therapy: a promising therapy for pain management.
   Zhang J, Wu P, Wen Q. · · 2024 · cited 4× · PMID 39020426 · DOI 10.1186/s13287-024-03828-8
5. Targeted therapy for knee osteoarthritis: From basic to clinics.
   Chen L, Huang FL, Tang Q, Zhao ZK, et al · · 2025 · cited 1× · PMID 40826764 · DOI 10.1097/md.0000000000043686