Hip OsteoarthritisPhase 1NCT01500811
Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis
A Phase 1 study testing cell injection in people with Hip Osteoarthritis, run by Royan Institute at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIran
- Study dates
- Mar 2011to Aug 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Osteoarthritis diagnosed by MRI
Who cannot join
- Pregnancy or lactating
- Positive tests for HIV, HCV, HBV
- Active neurologic disorder
- End organ damage
- Uncontrolled endocrine disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation the Side Effects of Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis
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.
Read the detailed description
In this phase I clinical study 6 patients with severe hip osteoarthritis will be recruited. All patients will have a cartilage biopsy taken from the knee cartilage non-weight bearing zone. Chodrocytes will be extracted and cultured for 4 weeks. Patients then will receive chondrocyte injection under the guide of fluoroscopy. Patients will be evaluated post injection for 6 months at time intervals. Parameters considered being evaluated are, adverse effects, pain intensity and joint physical function and cartilage repair. These effects are measured by Visual Analogue Scale, WOMAC, Harris Hip Score questionnaire and MRI.
- Conditions
- Hip Osteoarthritis
- Being tested
- cell injection
- Keywords
- chondrocyte hip osteoarthritis intra articular injection
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cell injectionBiological
Also called chondrocyte transplantation
Intra articular injection of chondrocyte
| Study group | Role | What they receive |
|---|---|---|
| chondrocyte | Experimental | Patients with sever hip osteoarthritis who underwent intra articular cell injection. Receives: Biological: cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
joint swelling
Evaluation the swelling of hip joint after cell injection by physical examination.
Measured: 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)
Measured: 2 months
dispenea
Evaluation the respiratory allergic reactions like dispenea by physical examination after cell injection.
Measured: 1 week
skin rash
Evaluation the skin allergic reactions like skin rash by physical examination after cell injection.
Measured: 1 week
Secondary outcomes (4)
Quantitative changes in pain intensity
Evaluation the quantitative changes in pain measured by Visual Analogue Scale 2months after cell injection in compare with base line (before cell transplantation)
Measured: 2 months
physical function improvement
Evaluation the physical function improvement Measured by WOMAC osteoarthritis index and Harris Hip Score 2 months after cell injection in compare with base line(before cell transplantation)
Measured: 2 months
subchondral bone edema
Evaluation the subchondral bone edema by MRI after cell transplantation.
Measured: 2 months
cartilage thickness
Evaluation the cartilage thickness by MRI after cell injection in compare with baseline (before cell injection)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteNasser Aghdami, MD,PhD, Study director, Head of Royan Cell therapy CenterMohsen Emadeddin, MD, Principal investigator, scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500811
- Sponsor's protocol ID
- Royan-Bone-009
- Status last verified
- Jan 2011
- First submitted
- 22 Dec 2011
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Side Effects of Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis
- ClinicalTrials.gov ID
- NCT01500811
- Acronym / sponsor ID
- Royan-Bone-009
- Conditions
- Hip Osteoarthritis
- Keywords
- chondrocyte hip osteoarthritis intra articular injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Mar 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 28 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this phase I clinical study 6 patients with severe hip osteoarthritis will be recruited. All patients will have a cartilage biopsy taken from the knee cartilage non-weight bearing zone. Chodrocytes will be extracted and cultured for 4 weeks. Patients then will receive chondrocyte injection under the guide of fluoroscopy. Patients will be evaluated post injection for 6 months at time intervals. Parameters considered being evaluated are, adverse effects, pain intensity and joint physical function and cartilage repair. These effects are measured by Visual Analogue Scale, WOMAC, Harris Hip Score questionnaire and MRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chondrocyte | Experimental | Biological: cell injectionPatients with sever hip osteoarthritis who underwent intra articular cell injection. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Osteoarthritis diagnosed by MRI
Key exclusion criteria (5 listed)
- Pregnancy or lactating
- Positive tests for HIV, HCV, HBV
- Active neurologic disorder
- End organ damage
- Uncontrolled endocrine disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cell injectionAlso: chondrocyte transplantationIntra articular injection of chondrocyte | Biological | chondrocyte |
Primary outcome
joint swelling
Time frame: 2 months
Evaluation the swelling of hip joint after cell injection by physical examination.
deterioration of joint function
Time frame: 2 months
evaluation the deterioration of joint function by physical examination 2 months after injection in compare with base line(before injection)
dispenea
Time frame: 1 week
Evaluation the respiratory allergic reactions like dispenea by physical examination after cell injection.
skin rash
Time frame: 1 week
Evaluation the skin allergic reactions like skin rash by physical examination after cell injection.
4 secondary outcomes
Quantitative changes in pain intensity
Time frame: 2 months
physical function improvement
Time frame: 2 months
subchondral bone edema
Time frame: 2 months
cartilage thickness
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
Related trials for Hip Osteoarthritis
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Nasser Aghdami, MD,PhD study director
Head of Royan Cell therapy Center
Mohsen Emadeddin, MD principal investigator
scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cell injection in people with Hip Osteoarthritis, run by Royan Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
joint swelling (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2014.