Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint

NCT01499056 | Completed Phase 1 DMC

• 1 other identifier: Royan-Bone-008
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hip Osteoarthritis

Keywords

osteoarthritis; hip joint; mesenchymal stem cell

Outcome Measures

Primary Outcomes (4)

• swelling of hip joint

  Evaluatin the swelling of hip joint by physical examination after intra articular injection.

  2 months

• deterioration of joint function

  Evaluation deterioration of joint function by physical examination after intra articular cell injection.

  2 months

• skin allergic reaction

  Evaluation the skin allergic reaction like erythema,rash,swelling after intra articular cell injection.

  1 week

• Respiratory reaction

  Evaluation the Respiratory reaction like dyspenea by physical examination after imtra articular cell injection.

  1 week

Secondary Outcomes (4)

• Quantitative changes in pain intensity

  2 months

• physical function improvement

  2 months

• subchondral bone edema

  2 months

• cartilage thickness

  2 months

Study Arms (1)

hip osteoarthritis

EXPERIMENTAL

The patients with hip joint osteoarthritis who underwent cell injection

Biological: stem cell injection

Interventions

stem cell injection BIOLOGICAL

intra articular inection of mesenchymal stem cell

hip osteoarthritis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy or lactating
• Positive tests for HIV, HCV, HBV
• Active neurologic disorder
• End organ damage
• Uncontrolled endocrine disorder

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Publications (1)

• 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.

  PMID: 26058927 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Hamid Gourabi, PhD

  Head of Royan Institute

  STUDY CHAIR

• Nasser Aghdami, MD,PhD

  Head of Royan Cell therapy Center

  STUDY DIRECTOR

• Mohsen Emadeddin, MD

  scientist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2011
• First Posted: December 26, 2011
• Study Start: June 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: December 26, 2011

Record last verified: 2010-01

Locations

IR (1)