Avascular Necrosis of the Femoral HeadNCT01643655
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Avascular Necrosis of the Femoral Head
A study testing Autologous Adipose Tissue derived MSCs Transplantation in people with Avascular Necrosis of the Femoral Head, run by R-Bio at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with avascular necrosis of the femoral head. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Avascular Necrosis of the Femoral Head
- What is being tested?
- Autologous Adipose Tissue derived MSCs Transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Mar 2015
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age :18-70, males and females.
- Subjects who understand and sign the consent form for this study.
- Clinical diagnosis of nontraumatic avascular necrosis of the femoral head
- Steinberg stage I, II, ⅢA
- Patients whose lesion is more than 30% (by Kim's Method)
Who cannot join
- Patients who have collapsed femoral head
- Patient has had a Core Decompression or Multiple Drilling in the affected hip
- Patients who received osteoporosis medicines and parathyroid hormone drugs
- Taking medications that use the immunosuppressive drugs and cytotoxic agents or unable to discontinue their use for the duration of the study
- Taking medications that use the adrenocortical hormone drugs or unable to discontinue their use for the duration of the study
- Subject unable to undergo MRI (i.e. patients with pace-maker, metallic hip prosthetic implants)
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- Women who are pregnant or breast feeding or planning to become pregnant during the study.
- Positive serology for HIV and hepatitis
- Serious pre-existing medical conditions like Cardiovascular Diseases, Cancer, Renal Diseases, Endocrine Diseases and Autoimmune Diseases
- Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study.
- Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Avascular Necrosis of the Femoral Head
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with avascular necrosis of the femoral head.
- Conditions
- Avascular Necrosis of the Femoral Head
- Being tested
- Autologous Adipose Tissue derived MSCs Transplantation
- Medical subject headings
- Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Adipose Tissue derived MSCs TransplantationProcedure or surgery
Into the Femoral Head infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 cells/3mL
| Study group | Role | What they receive |
|---|---|---|
| Autologous Adipose Tissue Derived MSCs | Experimental | Not described Receives: Procedure: Autologous Adipose Tissue derived MSCs Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Imaging
To evaluate the change of treated femoral head using Magnetic Resonance Imaging (MRI) at 24 months post injection of MSCs.
Measured: 96 weeks
Secondary outcomes (6)
SPECT/CT
To evaluate the change of treated femoral head using SPEC/CT at 24 months post injection of MSCs.
Measured: 96 weeks
Hip X-ray
To confirm the collapse of femoral head using Hip X-ray at 24 months post injection of MSCs.
Measured: 96 weeks
HHS (Harris Hip Score)
To evaluate the change of treated femoral head using Harris Hip Score at 24 months post injection of MSCs.
Measured: 96 weeks
WOMAC (Western Ontario and McMaster Universities) Index
To evaluate the change of treated femoral head using WOMAC Index at 24 months post injection of MSCs.
Measured: 96 weeks
UCLA (University of California Los Angeles) hip questionnaire
To evaluate the change of treated femoral head using UCLA hip questionnaire at 24 months post injection of MSCs.
Measured: 96 weeks
Safety evaluation
To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests.
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avascular Necrosis of the Femoral HeadStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Sponsor
- Investigators
- Kang-Sup Yoon, M.D. & Ph.D., Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643655
- Sponsor's protocol ID
- KSC-MSCs-AVN
- Status last verified
- Aug 2017
- First submitted
- 16 Jul 2012
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Avascular Necrosis of the Femoral Head
- ClinicalTrials.gov ID
- NCT01643655
- Acronym / sponsor ID
- KSC-MSCs-AVN
- Conditions
- Avascular Necrosis of the Femoral Head
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- R-BioIndustry (pharma, biotech, devices)
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- May 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 18 Jul 2012 (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.
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with avascular necrosis of the femoral head.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Adipose Tissue Derived MSCs | Experimental | Procedure: Autologous Adipose Tissue derived MSCs Transplantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age :18-70, males and females.
- Subjects who understand and sign the consent form for this study.
- Clinical diagnosis of nontraumatic avascular necrosis of the femoral head
- Steinberg stage I, II, ⅢA
- Patients whose lesion is more than 30% (by Kim's Method)
Key exclusion criteria (11 listed)
- Patients who have collapsed femoral head
- Patient has had a Core Decompression or Multiple Drilling in the affected hip
- Patients who received osteoporosis medicines and parathyroid hormone drugs
- Taking medications that use the immunosuppressive drugs and cytotoxic agents or unable to discontinue their use for the duration of the study
- Taking medications that use the adrenocortical hormone drugs or unable to discontinue their use for the duration of the study
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 |
|---|---|---|
| Autologous Adipose Tissue derived MSCs TransplantationInto the Femoral Head infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 cells/3mL | Procedure or surgery | Autologous Adipose Tissue Derived MSCs |
Primary outcome
Magnetic Resonance Imaging
Time frame: 96 weeks
To evaluate the change of treated femoral head using Magnetic Resonance Imaging (MRI) at 24 months post injection of MSCs.
6 secondary outcomes
SPECT/CT
Time frame: 96 weeks
Hip X-ray
Time frame: 96 weeks
HHS (Harris Hip Score)
Time frame: 96 weeks
WOMAC (Western Ontario and McMaster Universities) Index
Time frame: 96 weeks
UCLA (University of California Los Angeles) hip questionnaire
Time frame: 96 weeks
Safety evaluation
Time frame: 96 weeks
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 31 Aug 2017.
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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.
Kang-Sup Yoon, M.D. & Ph.D. principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Adipose Tissue derived MSCs Transplantation in people with Avascular Necrosis of the Femoral Head, run by R-Bio at 1 site in South Korea.
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 5 inclusion and 11 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 31 Aug 2017. 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 South Korea. 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.
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?
Magnetic Resonance Imaging (time frame: 96 weeks). 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 31 Aug 2017.