Articular Cartilage Resurfacing With Mesenchymal Stem Cells In Osteoarthritis Of Knee Joint

NCT ID: NCT01207661

Last Updated: 2012-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-11-30

Brief Summary

Knee osteoarthritis is the most common form of arthritis. Treatments involve high costs in terms of social and economic, are palliative and do not contemplate healing by regenerative therapy. It has been shown recently, that mesenchymal stem cells (MSC) can be expanded in vitro and may regenerate several damaged or injured tissues. In addition its has demonstrated that MSC are able to modulate immune responses and to control inflammation through its action on T lymphocytes. Preliminary studies in animal models, including one carried out in an equine by the investigators research group, confirms feasibility, safety and efficacy evidence proposed treatment protocol.This study is designed to evaluate therapeutic potential and safety of mesenchymal stem cells in improvement of osteoarthritis clinical manifestations.This study is designed to evaluate therapeutic potential and safety of mesenchymal stem cells in improvement of osteoarthritis clinical manifestations.

Detailed Description

Mesenchymal stem cells are pluripotent cells that can be obtained from various tissues .They have shown capabilities to differentiate into bone,cartilage,muscle,and adipose tissue, representing a new clinical strategy in regenerative medicine.An increasing number of reports have demonstrated effectiveness of percutaneous intra-articular infusion of MSCs in arthritic disease. In this study we perform a single intra articular injection of cultured mesenchymal stem cells in patients suffering from osteoarthritis, with the aim to assess its clinical safety and efficacy.Patients are assessed for response with MRI, X-Ray examination, WOMAC osteoarthritis index,VAS, and SF36 2,4,8 weeks and 6, and 12 months post infusion.

Conditions

Osteoarthritis

Study Design

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

Study Groups

Mesenchymal Injection

Intra Articular injection in Patients with osteoarthritis of knee joint

Group Type: EXPERIMENTAL

Mesenchymal Injection

Intervention Type: BIOLOGICAL

Intra Articular Injection of Mesenchymal cells to the knee joint

Interventions

Mesenchymal Injection

Intra Articular Injection of Mesenchymal cells to the knee joint

Intervention Type: BIOLOGICAL

Other Intervention Names

Cell Injection

Eligibility Criteria

Inclusion Criteria

• Female patients not pregnant or lactating.
• Patients with a history of corticosteroids or on active therapy, will only be eligible for enrollment if corticosteroid use is suspended for 1 month prior cell therapy
• Marcaine 0.75% و Lidocaine 4% test performed to be assure the exact location of the pain is related to the knee.
• Diagnosis must be based on magnetic resonance imaging.
• Both genders
• Age:18-65 years

Exclusion Criteria

• Diagnosis of cancer,DM,CNS disorder,thyroid disease or respiratory disease.
• Known allergic reaction to components of study treatment and/or study injection procedure
• Patients infected with hepatitis B,C or HIV.

• 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

Mohammad reza Baghban Eslami Nejad, PhD

Role: STUDY_DIRECTOR

Scientific Board

Mohssen Emadeddin, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopadic Investigator

Nasser Aghdami, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Head of Regeneration center

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

Related Info

Other Identifiers

Royan-Bone-002

Identifier Type: -

Identifier Source: org_study_id