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NCT Number: NCT01436058

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royan Institute

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesenchymal stem cell

Biological

intraarticular injection of mesenchymal stem cell in patients with ankle joint osteoarthritis

Other names: stem cell transplantation

Primary outcomes

  1. safety

    Time frame: 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 outcomes

  1. pain

    Time frame: 6 months

    evaluation the pain reduction in patients with ankle joint osteoarthritis after stem cell transplantation by filling the SF36

  2. physical function

    Time frame: 6 months

    evaluation the ability of patient to standing,walking,climb the steps after stem cell transplantation.

  3. defect

    Time frame: 6 months

    evaluation regeneration of ankle joint by serial MRI after stem cell transplantation based on changing the size of articular defect

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

Phase 1 Study of Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Patients With Ankle Joint Osteoarteritis

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 19, 2011
Registry last updated
Sep 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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