Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Ankle Joint Osteoartritis

Royan Institute

Status and phase: Completed; Phase 1

Conditions: Osteoarthritis

Treatments: Biological: mesenchymal stem cell

Study type: Interventional

Funder types: Other

Identifiers

NCT01436058

Royan-Bone-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

stem cell recipient

Experimental group

Description:

patients with ankle joint osteoarthritis

Treatment:

Biological: mesenchymal stem cell