Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis
Evaluation the Side Effects of Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis
1 other identifier
interventional
6
1 country
1
Brief Summary
Hip osteoarthritis is degeneration of hip cartilage and inflammation of subchondral bone and soft tissue linings. Patients have pain, stiffness, swelling, and difficulty walking. There are treatments available to help manage these symptoms like weight loss, and analgesics. Surgery is the appropriate treatment in patients who have failed these conservative treatments. The aim of this clinical study is to assess safety of autologous cultured chondrocyte intra-articular injection and obtain its clinical results in patients with severe hip osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2011
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 22, 2011
CompletedFirst Posted
Study publicly available on registry
December 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedApril 28, 2014
January 1, 2011
2.4 years
December 22, 2011
April 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
joint swelling
Evaluation the swelling of hip joint after cell injection by physical examination.
2 months
deterioration of joint function
evaluation the deterioration of joint function by physical examination 2 months after injection in compare with base line(before injection)
2 months
dispenea
Evaluation the respiratory allergic reactions like dispenea by physical examination after cell injection.
1 week
skin rash
Evaluation the skin allergic reactions like skin rash by physical examination after 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)
chondrocyte
EXPERIMENTALPatients with sever hip osteoarthritis who underwent intra articular cell injection.
Interventions
Intra articular injection of chondrocyte
Eligibility Criteria
You may qualify if:
- Osteoarthritis diagnosed by MRI
You may not qualify if:
- Pregnancy or lactating
- Positive tests for HIV, HCV, HBV
- Active neurologic disorder
- End organ damage
- Uncontrolled endocrine disorder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royan Institutelead
Study Sites (1)
Royan Institute
Tehran, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hamid Gourabi, PhD
Head of Royan Institute
- STUDY DIRECTOR
Nasser Aghdami, MD,PhD
Head of Royan Cell therapy Center
- PRINCIPAL INVESTIGATOR
Mohsen Emadeddin, MD
scientist
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 22, 2011
First Posted
December 28, 2011
Study Start
March 1, 2011
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
April 28, 2014
Record last verified: 2011-01