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NCT05515523 | NOT YET RECRUITING | Osteoarthritis

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

Wake Forest University Health Sciences

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).

Condition or disease

Osteoarthritis

Intervention/treatment

Adipose Derived (AD) Stromal Vascular Fraction (SVF)

Phase

EARLY_PHASE1

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 Type : INTERVENTIONAL
Estimated Enrollment : 10 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Pilot Trial of Intra-articular Stromal Vascular Fraction for the Treatment of Knee Post-Trauma Osteoarthritis and Biomarker Identification
Actual Study Start Date : 2024-10
Estimated Primary Completion Date : 2025-06
Estimated Study Completion Date : 2026-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 45 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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
Exclusion Criteria
  • * 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
  • * Subjects currently on worker's compensation
Stromal Vascular Fraction (SVF) for Knee Post-Trauma Osteoarthritis (PTOA)

Location Details

NCT05515523

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How to Participate

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Locations

Not yet recruiting

United States, North Carolina

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157