Stromal Vascular Fraction (SVF) for Knee Post-Trauma Osteoarthritis (PTOA)

NCT05515523 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: IRB00088231
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Osteoarthritis

Keywords

degenerative joint disease; degenerative arthritis; Knee trauma

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  number of safety events post injection

  Year 1

Other Outcomes (4)

• Knee Pain scores - Visual Analog Scale (VAS)

  Baseline, Month 1, Month 3, Month 6, and Year 1

• Knee Pain scores - The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Baseline, Month 1, Month 3, Month 6, and Year 1

• Synovial Fluid Inflammatory Biomarker measurements

  Baseline, Month 1, Month 3, Month 6, and Year 1

Study Arms (1)

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)

Genetic: Adipose Derived (AD) Stromal Vascular Fraction (SVF)

Interventions

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

a single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Joint Diseases

Condition Hierarchy (Ancestors)

Arthritis; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Claude T Moorman, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single injection of autologous Adipose Derived (AD) Stromal Vascular Fraction (SVF) for the treatment of knee Post Traumatic Osteoarthritis (PTOA)

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 25, 2022
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)