Articular Cartilage Resurfacing With Mesenchymal Stem Cel... | NCT01207661

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

NCT01207661

Sponsor

Royan Institute

Status

Completed

Last Update Posted

Jan 5, 2012Estimated

Enrollment

6Actual

Phase

Phase 1

Conditions

Osteoarthritis

Interventions

Mesenchymal Injection

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Sep 6, 2010

First Submission Date that Met QC Criteria

Sep 22, 2010

First Posted Date

Sep 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2012

Last Update Posted Date

Jan 5, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mesenchymal Injection	Experimental	Intra Articular injection in Patients with osteoarthritis of knee joint	Biological: Mesenchymal Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mesenchymal Injection	Biological	Intra Articular Injection of Mesenchymal cells to the knee joint	Mesenchymal Injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain relief	evaluation the effect of Mesenchymal stem cell transplantation to decrease the patients pain	6 months

Secondary Outcomes

Measure	Description	Time Frame
Pain relief	decrease the patient pain in VAS scale	6 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hamid Gourabi, PhD	Head of Royan Institute	Study Chair
Mohammad reza Baghban Eslami Nejad, PhD	Scientific Board	Study Director
Mohssen Emadeddin, MD	Orthopadic Investigator	Principal Investigator
Nasser Aghdami, MD,PhD	Head of Regeneration center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royan Institute		Tehran			Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26058927	Derived	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.

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D002265	Carboxylic Ester Hydrolases
D004950	Esterases
D006867	Hydrolases
D004798	Enzymes