Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Affected Knee Osteoarthritis by Rheumatoid Arthritis

NCT ID: NCT01873625

Last Updated: 2013-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-12-31

Brief Summary

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Osteoarthritis of the knee is one of the most common causes of disability among elderly. Arthritis rheumatoid is an autoimmune disease which causes multi articular arthritis, such as knee osteoarthritis. As the disease progresses the cartilage become frustrated, surrounding bone react to become thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in signal density. Patients are treated initially by pain management. In patients who don't response to first line treatment invasive treatment like total knee replacement is done. The investigators designed this clinical study with the aim of evaluating therapeutic effects of intra-articular injection of bone marrow mesenchymal stem cells (BM-MSCs) in 60 patients with knee osteoarthritis.

Detailed Description

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In this study all eligible patients were randomly allocated into two study groups by a permuted block randomization method: group A (control group) received only routine medical therapies and placebo injected into there knees.. Group B received mesenchymal stem cells in addition of routine medical therapy.

Patients were categorized according to the following stimulation protocols:

To assess the outcomes, after mesenchymal stem cells transplantation at months 1,3,6 and 12 we will examine the patients by: WOMAC questioners, DAS28 scoring , radiographies assessments and biochemical analysis with laboratory tests.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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placebo

Normal salin injection in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

mesencymal stem cell

Mesenchymal stem cell transplantation in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.

Group Type ACTIVE_COMPARATOR

mesenchymal cell transplantation

Intervention Type BIOLOGICAL

Mesenchymal stem cell transplantation in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.

Interventions

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mesenchymal cell transplantation

Mesenchymal stem cell transplantation in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.

Intervention Type BIOLOGICAL

placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Age 18 to 65 years
2. Body mass index (BMI) ≤30 kg/m2
3. The presence of osteoarthritis based on MRI and American Rheumatism Association criteria since 6 months before invitation

Exclusion Criteria

1\. Response to routine treatment at last one year.
Minimum Eligible Age

10 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royan Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

Nasser Aghdami, MD,PhD

Role: STUDY_DIRECTOR

Head of regenerative medicine department, head of Royan cell therapy center

Mohsen Emadedin, MD

Role: STUDY_DIRECTOR

Royan Institute,Department of regenerative medicine

Farhad gharibdoost, MD

Role: STUDY_DIRECTOR

President of rheumatologic association center of Iran

Soraya Shadmanfar, MD

Role: PRINCIPAL_INVESTIGATOR

Royan Institute, Department of regenerative medicine

Locations

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Royan Institute

Tehran, , Iran

Site Status

Countries

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Iran

References

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Shadmanfar S, Labibzadeh N, Emadedin M, Jaroughi N, Azimian V, Mardpour S, Kakroodi FA, Bolurieh T, Hosseini SE, Chehrazi M, Niknejadi M, Baharvand H, Gharibdoost F, Aghdami N. Intra-articular knee implantation of autologous bone marrow-derived mesenchymal stromal cells in rheumatoid arthritis patients with knee involvement: Results of a randomized, triple-blind, placebo-controlled phase 1/2 clinical trial. Cytotherapy. 2018 Apr;20(4):499-506. doi: 10.1016/j.jcyt.2017.12.009. Epub 2018 Feb 7.

Reference Type DERIVED
PMID: 29428486 (View on PubMed)

Related Links

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Other Identifiers

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Royan-RA-001

Identifier Type: -

Identifier Source: org_study_id

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