OsteoarthritisNCT03166410
Use of Autologous Adipose-Derived Stromal Vascular Fraction To Treat Osteoarthritis of Hip, Knee, Ankle, and Thumb Joints
A study testing Cell injection in people with Osteoarthritis, run by Texas Plastic Surgery at 1 site in United States.
Trial summary
This study will examine the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF) cells for treatment of hip, knee and thumb osteoarthritis (OA); monitoring adverse events and measuring pain, function and stiffness in the joints of osteoarthritic subjects. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Cell injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Jul 2021
- 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 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade II through Grade IV hip, knee, ankle osteoarthritis using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray, physician review, and/or pre-op MRI
- Stage II through IV carpometacarpal (CMC) osteoarthritis using Eaton-Little's staging of CMC OA as diagnosed by X-ray and physical examination
- Study Subjects must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed
- Subjects with ASA grade I, II, or III
- Males and females 25-85 years old
- Subjects must have continued pain in their targeted/treatment joint despite conservative therapies for at least 3 months
Who cannot join
- Subjects that are allergic to lidocaine, epinephrine or valium
- Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be stopped as follows prior to injection; Thrombolytics and anti-platelet medication including but not limited to Coumadin (warfarin) for 3 days, Plavix (clopidogrel) for 3 days, acetylsalicylic acid (ASA)/NSAIDs/fish oil supplements for 7 days, Xeralta® (rivaroxaban) for 24 hours
- Subjects with systemic immunosuppressant use within six (6) weeks from screening and subjects with HIV/viral hepatitis
- Subjects with chondrocalcinosis, Paget's disease and Villonodular synovitis
- Women that are pregnant or planning to become pregnant during the study
- Subjects on long term use of oral steroids
- History of any chemotherapy or radiation therapy on the targeted/treatment joint or adipose harvest site
Trial locations and contacts
1 site in 1 country.
Texas Plastic Surgery contact
United States1 site, 1 recruiting
- Recruiting
Texas Plastic Surgery
San Antonio, Texas, 78240
About this study
This study will examine the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF) cells for treatment of hip, knee and thumb osteoarthritis (OA); monitoring adverse events and measuring pain, function and stiffness in the joints of osteoarthritic subjects.
- Conditions
- Osteoarthritis
- Being tested
- Cell injection
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell injectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Cell Treatment | Experimental | Not described Receives: Procedure: Cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Incidence of Treatment-Emergent Adverse Events
Subjects will be monitored for adverse events
Measured: 1 year
Secondary outcomes (1)
Efficacy - Change in Pain Scores at All Follow-up Visits
Pain scores will be collected at all visits
Measured: 3 months, 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study startJan 2017
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Plastic Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Jaime R. Garza, MD, Texas Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166410
- Sponsor's protocol ID
- SVFOA-01
- Status last verified
- Mar 2020
- First submitted
- 22 May 2017
- Last updated
- 13 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Autologous Adipose-Derived Stromal Vascular Fraction To Treat Osteoarthritis of Hip, Knee, Ankle, and Thumb Joints
- ClinicalTrials.gov ID
- NCT03166410
- Acronym / sponsor ID
- SVFOA-01
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Texas Plastic SurgeryIndustry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 25 May 2017 (actual)
- 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.
This study will examine the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF) cells for treatment of hip, knee and thumb osteoarthritis (OA); monitoring adverse events and measuring pain, function and stiffness in the joints of osteoarthritic subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cell Treatment | Experimental | Procedure: Cell injection |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Grade II through Grade IV hip, knee, ankle osteoarthritis using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray, physician review, and/or pre-op MRI
- Stage II through IV carpometacarpal (CMC) osteoarthritis using Eaton-Little's staging of CMC OA as diagnosed by X-ray and physical examination
- Study Subjects must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed
- Subjects with ASA grade I, II, or III
- Males and females 25-85 years old
Key exclusion criteria (7 listed)
- Subjects that are allergic to lidocaine, epinephrine or valium
- Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be stopped as follows prior to injection; Thrombolytics and anti-platelet medication including but not limited to Coumadin (warfarin) for 3 days, Plavix (clopidogrel) for 3 days, acetylsalicylic acid (ASA)/NSAIDs/fish oil supplements for 7 days, Xeralta® (rivaroxaban) for 24 hours
- Subjects with systemic immunosuppressant use within six (6) weeks from screening and subjects with HIV/viral hepatitis
- Subjects with chondrocalcinosis, Paget's disease and Villonodular synovitis
- Women that are pregnant or planning to become pregnant during 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 |
|---|---|---|
| Cell injection | Procedure or surgery | Cell Treatment |
Primary outcome
Safety - Incidence of Treatment-Emergent Adverse Events
Time frame: 1 year
Subjects will be monitored for adverse events
1 secondary outcome
Efficacy - Change in Pain Scores at All Follow-up Visits
Time frame: 3 months, 6 months, 1 year, 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
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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.
Texas Plastic Surgery contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cell injection in people with Osteoarthritis, run by Texas Plastic Surgery at 1 site in United States.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Mar 2020. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Texas Plastic Surgery (info@txps.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Incidence of Treatment-Emergent Adverse Events (time frame: 1 year). 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 13 Mar 2020.