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Cell therapies in Primary OA Knee

comparative analysis of cellular versus acellular therapies in primary knee osteoarthritis-A double blinded, unicentric, randomized controlled trial - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097974
Enrollment
300
Registered
2025-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M170- Bilateral primary osteoarthritis of knee

Interventions

Intervention1: Cell therapy: Group A: Intraarticular BMAC injection - 5 ml single dose - Intra-articular injection on day 0 Group B: Intraarticular SVF injection - 5 ml single dose - Intra-articular

Sponsors

Anandanarayan M
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with age between 40 to 60 years of both sex Patients OA knee Grade II and III. Primary OA knee patients not responding to analgesics Patients who are willing to take part in the study after informed consent

Exclusion criteria

Exclusion criteria: Post-traumatic knee Stiffness History of Infective joint disease Patients with a history of previous surgeries on the knee. Co-morbid / Pathology of ipsilateral Hip/ foot joint pathology Patients with rheumatoid arthritis, inflammatory arthritis or polyarticular arthritis, and autoimmune diseases Any other defect of the ipsilateral limb like Shortening etc. Patients with h/o prior corticosteroid injection at a treatment site within 3 months of duration Staging of the patients will be done by Kellgren and Lawrence criteria for assessment stage of osteoarthritis. Preoperative and postoperative weight-bearing and whole

Design outcomes

Primary

MeasureTime frame
To assess the pain relief of cellular versus acellular therapies in primary osteoarthritis knee with VAS score at different follow-up time points.Timepoint: Day 0 end of 1,3,6,12,24 months

Secondary

MeasureTime frame
To evaluate the functional outcome of cellular versus acellular therapies in primary osteoarthritis knee with WOMAC and KOOS at different follow-up time pointsTimepoint: Day 0 1,3,6,12,24 months;To compare the cartilage thickness and the healing of subchondral bone lesions of cellular versus acellular therapies in primary osteoarthritis knee via MOCART 2.O at a 2-year time point using MRI. Timepoint: day 0 and 24th month

Countries

India

Contacts

Public ContactAnandanarayan M

Faculty of Medicine - Sri Lalithambigai Medical college and Hospital

madhanjeyaraman@gmail.com8310600785

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026