OsteoarthritisEarly Phase 1SVFNCT05515523
Stromal Vascular Fraction (SVF) for Knee Post-Trauma Osteoarthritis (PTOA)
A Early Phase 1 study testing Adipose Derived (AD) Stromal Vascular Fraction (SVF) in people with Osteoarthritis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This is a prospective, non-randomized, interventional, dual site, before-after clinical trial to determine feasibility and safety of a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) for the treatment of knee Post Traumatic Osteoarthritis (PTOA). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Adipose Derived (AD) Stromal Vascular Fraction (SVF)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2026to Nov 2027
- Phase
- Early 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females 18 - 45 with a preceding history (>1 and < 20 years ago) of significant knee trauma or trauma- related knee surgery
- Post-Trauma Osteoarthritis (PTOA) as diagnosed by K-L Grade II or III OA (weight bearing X-ray) and physician review
- Subjects must present with symptomatic (injured knee) visual analog scale (VAS) pain > 4. If bilateral disease, Knee Osteoarthritis (KOA) pain in the other knee must be less than/equal to 3 on the VAS for pain
- Subjects must have an adjusted Western Ontario and McMaster Universities Arthritis Index (WOMAC) (100-point scale) of > 25 and <90
- Study Subjects must have continued knee pain despite at least two conservative prescribed therapies (pain medications, physical therapy, knee injections, or weight loss), spanning a period of at least 3 months
- 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
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- Subjects will be in good health (ASA Class I-II) with a Body mass index (BMI) < 35
- Subjects must speak, read, and understand English
- Subjects must be reasonably able to return for multiple follow-up visits, to include procedure visits
Who cannot join
- Subjects whose knee pain is caused by, (i) diffuse edema, (ii) cartilage lesion greater than 1 cm width and grade 4 depth by MRI or (iii) osteochondritis dissecans
- Subjects who have had surgery of either knee within 12 months prior to the screening visit
- Subjects who have had an injection in either knee in the prior 3 months, including corticosteroids, viscosupplementation, stem cells, or platelet rich plasma (PRP)
- Subjects who have gout, rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, severe bone deformity, infection of the knee joint, fibromyalgia, or neurogenic or vascular claudication
- Subjects who have symptomatic Osteoarthritis (OA) of the hips, spine, or ankle that would interfere with the evaluation of the treated knee
- Subjects that are unwilling to stop taking prescription or over the counter pain and anti-inflammatory medication for 7 days prior to any visit
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- Subjects that are allergic to lidocaine, epinephrine, or valium or other sedatives
- Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be stopped prior to IA injection
- Subjects with systemic immunosuppressant use within six (6) weeks from screening
- Subjects with human immunodeficiency virus (HIV)/viral hepatitis B or human T-lymphotropic virus type 1 (C/HTLV)
- Subjects with chondrocalcinosis, Paget's disease and Villonodular synovitis
- Subjects that use any form of tobacco
- Women that are pregnant or planning to become pregnant during the study
- Subjects on long term use of oral steroids or disease-modifying anti-rheumatic drugs
- History of any chemotherapy or radiation therapy of the targeted/treatment leg or adipose harvest site
- Subjects currently on worker's compensation
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Pilot Trial of Intra-articular Stromal Vascular Fraction for the Treatment of Knee Post-Trauma Osteoarthritis and Biomarker Identification
This is a prospective, non-randomized, interventional, dual site, before-after clinical trial to determine feasibility and safety of a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) for the treatment of knee Post Traumatic Osteoarthritis (PTOA).
Read the detailed description
Clinical treatment generally involves a life-long combination of exercise, lifestyle modifications, and/or analgesics. If pain becomes debilitating, different surgical options exist, including arthroscopic joint debridement and mechanical axis change through osteotomies around the knee and eventually joint replacement surgery for severe cases to improve the quality of life. However, patients under 40 years of age, who expect to continue an active lifestyle, have only a 40% "good or excellent" function score after total knee replacement, they are most likely to outlive their initial replacement and need revision.
- Conditions
- Osteoarthritis
- Being tested
- Adipose Derived (AD) Stromal Vascular Fraction (SVF)
- Keywords
- degenerative joint disease, degenerative arthritis, Knee trauma
- Medical subject headings
- Osteoarthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose Derived (AD) Stromal Vascular Fraction (SVF)Genetic
autologous stromal vascular fraction cells from adipose tissue for reintroduction to the same patient during a single surgical procedure for treatment of pain and function associated with OA of the knee joint
| Study group | Role | What they receive |
|---|---|---|
| a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) | Experimental | a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) for the treatment of knee Post Traumatic Osteoarthritis (PTOA) Receives: Genetic: Adipose Derived (AD) Stromal Vascular Fraction (SVF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
number of safety events post injection
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study startFeb 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Why it stopped: Lack of Funding
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.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) for the treatment of knee Post Traumatic Osteoarthritis (PTOA)
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claude T Moorman, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515523
- Sponsor's protocol ID
- IRB00088231
- Acronym
- SVF
- Status last verified
- Jul 2025
- First submitted
- 22 Aug 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Intra-articular Stromal Vascular Fraction for the Treatment of Knee Post-Trauma Osteoarthritis and Biomarker Identification
- ClinicalTrials.gov ID
- NCT05515523
- Acronym / sponsor ID
- SVF / IRB00088231
- Conditions
- Osteoarthritis
- Keywords
- degenerative joint disease, degenerative arthritis, Knee trauma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 25 Aug 2022 (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 is a prospective, non-randomized, interventional, dual site, before-after clinical trial to determine feasibility and safety of a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) for the treatment of knee Post Traumatic Osteoarthritis (PTOA).
Detailed description
Clinical treatment generally involves a life-long combination of exercise, lifestyle modifications, and/or analgesics. If pain becomes debilitating, different surgical options exist, including arthroscopic joint debridement and mechanical axis change through osteotomies around the knee and eventually joint replacement surgery for severe cases to improve the quality of life. However, patients under 40 years of age, who expect to continue an active lifestyle, have only a 40% "good or excellent" function score after total knee replacement, they are most likely to outlive their initial replacement and need revision.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) for the treatment of knee Post Traumatic Osteoarthritis (PTOA)
| Arm | Type | Receives |
|---|---|---|
| a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) | Experimental | Genetic: Adipose Derived (AD) Stromal Vascular Fraction (SVF)a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) for the treatment of knee Post Traumatic Osteoarthritis (PTOA) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Males and females 18 - 45 with a preceding history (>1 and < 20 years ago) of significant knee trauma or trauma- related knee surgery
- Post-Trauma Osteoarthritis (PTOA) as diagnosed by K-L Grade II or III OA (weight bearing X-ray) and physician review
- Subjects must present with symptomatic (injured knee) visual analog scale (VAS) pain > 4. If bilateral disease, Knee Osteoarthritis (KOA) pain in the other knee must be less than/equal to 3 on the VAS for pain
- Subjects must have an adjusted Western Ontario and McMaster Universities Arthritis Index (WOMAC) (100-point scale) of > 25 and <90
- Study Subjects must have continued knee pain despite at least two conservative prescribed therapies (pain medications, physical therapy, knee injections, or weight loss), spanning a period of at least 3 months
Key exclusion criteria (16 listed)
- Subjects whose knee pain is caused by, (i) diffuse edema, (ii) cartilage lesion greater than 1 cm width and grade 4 depth by MRI or (iii) osteochondritis dissecans
- Subjects who have had surgery of either knee within 12 months prior to the screening visit
- Subjects who have had an injection in either knee in the prior 3 months, including corticosteroids, viscosupplementation, stem cells, or platelet rich plasma (PRP)
- Subjects who have gout, rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, severe bone deformity, infection of the knee joint, fibromyalgia, or neurogenic or vascular claudication
- Subjects who have symptomatic Osteoarthritis (OA) of the hips, spine, or ankle that would interfere with the evaluation of the treated knee
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 |
|---|---|---|
| Adipose Derived (AD) Stromal Vascular Fraction (SVF)autologous stromal vascular fraction cells from adipose tissue for reintroduction to the same patient during a single surgical procedure for treatment of pain and function associated with OA of the knee joint | Genetic | a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) |
Primary outcome
Number of Adverse Events
Time frame: Year 1
number of safety events post injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Claude T Moorman, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Adipose Derived (AD) Stromal Vascular Fraction (SVF) in people with Osteoarthritis, run by Wake Forest University Health Sciences 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 9 inclusion and 16 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: withdrawn, as of the sponsor's last update on 27 Feb 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was withdrawn before enrolling participants, so there are no results.
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?
Number of Adverse Events (time frame: Year 1). 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 27 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.