Clinical trial NCT01207661: Articular Cartilage Resurfacing With Mesenchymal Stem Cells In Osteoarthritis Of Knee Joint
Official title: Mesenchymal Stem Cells Transplantation for Articular Cartilage Resurfacing in Patient With Osteoarthritis of Knee Joint
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis
Keywords: Mesenchymal cells
osteoarthritis
intra articular injection
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2010-09-23
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain relief
timeFrame: 6 months
Secondary outcomes:
measure: Pain relief
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Scientific Board
name: Mohammad reza Baghban Eslami Nejad, PhD
role: STUDY_DIRECTOR
affiliation: Orthopadic Investigator
name: Mohssen Emadeddin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of Regeneration center
name: Nasser Aghdami, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.