NCT01873625

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Oct 2009

Typical duration for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
Last Updated

June 10, 2013

Status Verified

August 1, 2009

Enrollment Period

1.4 years

First QC Date

June 5, 2013

Last Update Submit

June 7, 2013

Conditions

Rheumatoid Arthritis

Keywords

mesenchymal stem cellsosteoarthritisarthritis rheumatoid

Outcome Measures

Primary Outcomes (3)

  • pain

    Evaluation the pain reduction after mesenchymal stem cell transplantation that measured by VAS scaling.

    1month

  • physical activity

    evaluation the improvement of physical activity after mesenchymal stem cell transplantation that measured by WOMAC scoring.

    1month

  • walking distance

    Evaluation the walking distance after mesenchymal transplantation.

    1month

Secondary Outcomes (1)

  • Imaging

    6months

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

Biological: placebo

mesencymal stem cell

ACTIVE COMPARATOR

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

Biological: mesenchymal cell transplantation

Interventions

mesenchymal cell transplantationBIOLOGICAL

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

mesencymal stem cell
placeboBIOLOGICAL
placebo

Eligibility Criteria

Age10 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \. Response to routine treatment at last one year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Publications (1)

  • 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.

    PMID: 29428486DERIVED

Related Links

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoarthritis

Interventions

Mesenchymal Stem Cell Transplantation

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Stem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Hamid Gourabi, PhD

    Head of Royan Institute

    STUDY CHAIR

  • Nasser Aghdami, MD,PhD

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

    STUDY DIRECTOR

  • Mohsen Emadedin, MD

    Royan Institute,Department of regenerative medicine

    STUDY DIRECTOR

  • Farhad gharibdoost, MD

    President of rheumatologic association center of Iran

    STUDY DIRECTOR

  • Soraya Shadmanfar, MD

    Royan Institute, Department of regenerative medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2013

First Posted

June 10, 2013

Study Start

October 1, 2009

Primary Completion

March 1, 2011

Study Completion

December 1, 2011

Last Updated

June 10, 2013

Record last verified: 2009-08

Locations

IR(1)