Osteoarthritis of the hip is a common type of osteoarthritis which can cause significant problems. First-line of management for patient with osteoarthritis consists of weight reduction, education, and analgesic medication. If necessary, invasive treatment like total hip replacement are performed for the patient. The objective of this study was to assess the safety of bone marrow mesenchymal stem cells (BM-MSCs) implantation in patients with hip osteoarthritis
This is a phase one clinical study designed to investigate the safety of intra-articular injection of cultured autologous BM-MSCs in patients with severe hip osteoarthritis candidate for total hip replacement. All subjects will undergo bone marrow aspiration. Autologous MSCs will be extracted and cultured for 4 weeks. Patients will receive intra-articular injection of cultured MSCs under the guide of fluoroscopy. Paraclinical studies (X-Ray and MRI) will be done before and 6 months after treatment. Pain relief and functional improvement of the joint will be assessed by VAS, WOMAC, and Harris Hip Score questionnaire before treatment, and 2 and 6 months after treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
intra articular inection of mesenchymal stem cell
Royan Institute
Tehran, Iran
swelling of hip joint
Evaluatin the swelling of hip joint by physical examination after intra articular injection.
Time frame: 2 months
deterioration of joint function
Evaluation deterioration of joint function by physical examination after intra articular cell injection.
Time frame: 2 months
skin allergic reaction
Evaluation the skin allergic reaction like erythema,rash,swelling after intra articular cell injection.
Time frame: 1 week
Respiratory reaction
Evaluation the Respiratory reaction like dyspenea by physical examination after imtra articular cell injection.
Time frame: 1 week
Quantitative changes in pain intensity
Evaluation Quantitative changes in pain intensity measured by Visual Analogue Scale after intra articular cell injection 2 months after cell transplantation in compare with base line (before injection)
Time frame: 2 months
physical function improvement
Evaluation the physical function improvement Measured by WOMAC osteoarthritis index and Harris Hip Score.
Time frame: 2 months
subchondral bone edema
Evaluation the subchondral bone edema by MRI
Time frame: 2 months
cartilage thickness
measuring the cartilage thickness after cell transplantation by MRI
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Time frame: 2 months