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

NCT ID: NCT01436058

Last Updated: 2011-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-09-30

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

stem cell recipient

patients with ankle joint osteoarthritis

Group Type: EXPERIMENTAL

mesenchymal stem cell

Intervention Type: BIOLOGICAL

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

Interventions

mesenchymal stem cell

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

Intervention Type: BIOLOGICAL

Other Intervention Names

stem cell transplantation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royan Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

Nasser Aghdami, MD,PhD

Role: STUDY_DIRECTOR

Head of Royan Cell therapy Center

Mohsen Emadeddin, MD

Role: PRINCIPAL_INVESTIGATOR

orthopedic scientists

Locations

Royan Institute

Tehran, , Iran

Countries

Iran

References

Emadedin M, Ghorbani Liastani M, Fazeli R, Mohseni F, Moghadasali R, Mardpour S, Hosseini SE, Niknejadi M, Moeininia F, Aghahossein Fanni A, Baghban Eslaminejhad R, Vosough Dizaji A, Labibzadeh N, Mirazimi Bafghi A, Baharvand H, Aghdami N. Long-Term Follow-up of Intra-articular Injection of Autologous Mesenchymal Stem Cells in Patients with Knee, Ankle, or Hip Osteoarthritis. Arch Iran Med. 2015 Jun;18(6):336-44.

Reference Type: DERIVED

PMID: 26058927 (View on PubMed)

Related Links

http://www.royaninstitute.org/cmsen/index.php

Related Info

Other Identifiers

Royan-Bone-007

Identifier Type: -

Identifier Source: org_study_id