Status:
COMPLETED
Autologous Bone Marrow Aspirate Concentrate Injection for the Treatment of Early Osteoarthritis:Baghdad 2022
Lead Sponsor:
Global Stem Cell Center, Baghdad
Conditions:
Treatment Complication
Eligibility:
All Genders
55-85 years
Phase:
NA
Brief Summary
We present a randomized controlled trial (RCT) to assess the efficacy of autologous bone marrow aspirate concentrate BMAC of 1.8x 10 9 median cellular content in the treatment of early symptomatic knee...
Detailed Description
1. To evaluate the efficacy of bone marrow aspirate concentrate (BMAC) therapy on pain, function and disease modification in knee osteoarthritis. 2. To determine the potential of BMAC therapy to achie...
Eligibility Criteria
Inclusion
- Radiological diagnosis of Osteoarthritis according to Kellgren and Lawrence Criteria stage II-III.
- Radiological grading of osteoarthritis of the knee determined by qualified radiologist using MOAKS scoring system.
- Primary osteoarthritis not responsive to conventional treatment and physiotherapy.
- A minimum pain score of 5 on an 11-point numerical scale.
- Age \>55 years
Exclusion
- Pregnancy and breast feeding.
- Knee symptom due to other condition like tumor or referred pain from lumbar spine.
- MRI confirmed displaced meniscal tear
- MRI confirmed Grade IV chondral loss.
- Previous knee surgery within the last 12 months.
- Previous intra-articular injectable therapies within the last 6 months
- History of severe systemic illness.
- Active neoplasm under treatment in the last 12 months- Health conditions including known allergy to local
- Bleeding tendency.
Key Trial Info
Start Date :
February 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05193877
Start Date
February 8 2022
End Date
January 16 2024
Last Update
January 17 2024
Active Locations (1)
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1
Ministry of Health
Baghdad, Iraq, 964