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Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint

NCT ID: NCT01499056

Last Updated: 2011-12-26

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

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-03-31

Brief Summary

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Osteoarthritis of the hip is a common type of osteoarthritis which can cause significant problems. First-line of management for patient with osteoarthritis consists of weight reduction, education, and analgesic medication. If necessary, invasive treatment like total hip replacement are performed for the patient. The objective of this study was to assess the safety of bone marrow mesenchymal stem cells (BM-MSCs) implantation in patients with hip osteoarthritis

Detailed Description

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This is a phase one clinical study designed to investigate the safety of intra-articular injection of cultured autologous BM-MSCs in patients with severe hip osteoarthritis candidate for total hip replacement. All subjects will undergo bone marrow aspiration. Autologous MSCs will be extracted and cultured for 4 weeks. Patients will receive intra-articular injection of cultured MSCs under the guide of fluoroscopy. Paraclinical studies (X-Ray and MRI) will be done before and 6 months after treatment. Pain relief and functional improvement of the joint will be assessed by VAS, WOMAC, and Harris Hip Score questionnaire before treatment, and 2 and 6 months after treatment.

Conditions

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Hip Osteoarthritis

Keywords

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osteoarthritis hip joint mesenchymal stem cell

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hip osteoarthritis

The patients with hip joint osteoarthritis who underwent cell injection

Group Type EXPERIMENTAL

stem cell injection

Intervention Type BIOLOGICAL

intra articular inection of mesenchymal stem cell

Interventions

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stem cell injection

intra articular inection of mesenchymal stem cell

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Osteoarthritis diagnosed by MRI
* End stage osteoarthritis candidate for total hip replacement

Exclusion Criteria

* Pregnancy or lactating
* Positive tests for HIV, HCV, HBV
* Active neurologic disorder
* End organ damage
* Uncontrolled endocrine disorder
Minimum Eligible Age

18 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 Royan Cell therapy Center

Mohsen Emadeddin, MD

Role: PRINCIPAL_INVESTIGATOR

scientist

Locations

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Royan Institute

Tehran, , Iran

Site Status

Countries

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Iran

References

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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)

Other Identifiers

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Royan-Bone-008

Identifier Type: -

Identifier Source: org_study_id