Osteoarthritis
Conditions
Keywords
side effect, mesenchymal stem cell, ankle, osteoarthritis
Brief summary
Ankle osteoarthritis is a joint condition which results from damage and loss of the cartilage in a joint. Treatment options for ankle osteoarthritis are usually aimed at controlling pain and limiting motion that provokes the pain. Nonsurgical treatment approaches are tried first. If unsuccessful, surgical options are considered. Stem cell therapy is one of the therapeutic options that can repair the damaged cartilage. Bone marrow derived mesenchymal stem cells have showed the capacity of bone and cartilage regeneration.
Detailed description
In this clinical study the investigators aim to investigate the safety of intra-articular injection of cultured autologous bone marrow derived mesenchymal stem cells (BM-MSCs) to the ankle joint in patients with severe ankle osteoarthritis. Patients will undergo bone marrow aspiration and will receive cultured BM-MSCs one month later. Patients will be assessed clinically with scoring system (FAO, VAS, WOMAC) preoperatively as well as 2 and 6 months postoperative to measure pain reduction and joint function improvement. Paraclinical studies (X-Ray and MRI) will be performed before and 6 months after treatment.
Interventions
BIOLOGICALmesenchymal stem cell
intraarticular injection of mesenchymal stem cell in patients with ankle joint osteoarthritis
Sponsors
Royan Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Osteoarthritis diagnosed by MRI * End stage osteoarthritis candidate for total ankle replacement
Exclusion criteria
* Pregnancy or lactating * Positive tests for HIV, HCV, HBV * Active neurologic disorder * End organ damage * Uncontrolled endocrine disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety | 6 months | Evaluate Safety of intra-articular injection of autologous cultured mesenchymal stem cells in patients with ankle osteoarthritis (time frame : baseline, 2 months, 6 months)by filling the check list of side effects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain | 6 months | evaluation the pain reduction in patients with ankle joint osteoarthritis after stem cell transplantation by filling the SF36 |
| physical function | 6 months | evaluation the ability of patient to standing,walking,climb the steps after stem cell transplantation. |
| defect | 6 months | evaluation regeneration of ankle joint by serial MRI after stem cell transplantation based on changing the size of articular defect |
Countries
Iran
Outcome results
None listed