Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis

Part of paid clinical trials in Valencia, California.

Sponsor
Healeon Medical Inc
Study ID
NCT04238143
Status
Recruiting
Apply to this trial

Conditions

  • Osteo Arthritis Knee
  • Osteo Arthritis Shoulders
  • Osteoarthritis
  • Osteoarthritis - Ankle/Foot
  • Osteoarthritis of Multiple Joints
  • Osteoarthritis, Hip

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Tissue Stromal Vascular Fraction (tSVF) Arm 1 — PROCEDURE
    Harvesting subcutaneous tSVF with sterile, disposable microcannula system
  • PRP Concentrate Arm 1 — BIOLOGICAL
    Preparation of PRP Concentrate via sterile Terumo-Harvest System
  • Tissue Stromal Vascular Fraction (tSVF) Arm 2 — PROCEDURE
    Harvesting subcutaneous tSVF with sterile, disposable microcannula system
  • PRP Concentrate Arm 2 — BIOLOGICAL
    Preparation of PRP Concentrate via sterile Terumo-Harvest System
  • Cellular Stromal Vascular Fraction (cSVF) Arm 2 — PROCEDURE
    Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)
  • Cellular Stromal Vascular Fraction (cSVF) Arm 3 — PROCEDURE
    Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)
  • Sterile Normal Saline (IV Solution) — DRUG
    Suspension of cSVF in 500 cc Sterile Normal Saline (IV Solution)

Study Details

Use of Biocellular and cellular approaches to treatment of Osteoarthritis (OA), musculoskeletal aging processes, pain, and degenerative changes are to be studied with minimally invasive protocols, and non-pharmaceutical means to relieve OA and its associated issues. Traditional surgical interventions have not yielded convincing long-term outcomes, including total joint replacement surgeries and medical management of the supportive structures. This study is to use a person's own stem/stromal Cells (autologous) plus HD-PRP (important healing growth factors and signal molecules) in such cases of OA for long-term minimally invasive treatments. Baseline (existing) findings are documented, and thence tracked as to progress deemed to be result of the intervention.

Key Dates

Start date
Jan 10, 2020
Status verified
Sep 2024
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: tSVF + PRP Arm1
    Tissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) Concentrate
  • Experimental: tSVF + PRP + cSVF Arm 2
    Tissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) Concentrate + Cellular Stromal Vascular Fraction (cSVF)
  • Experimental: Normal Saline IV + cSVF Arm 3
    Cellular Stromal Vascular Fraction (cSVF); Sterile Normal Saline Intravenous (IV) Introduction

Primary Outcome Measure

Participant with Complications [ Time Frame: 6 Months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Hemwall Center for Orthopedic Regenerative MedicineValenciaCalifornia91355
Kelly Cirricone, BS
[email protected]
661-295-1110
Regenevita LLCStevensvilleMontana59870
Glenn C Terry, MD
[email protected]
706-566-9141
Heather Terry
[email protected]
17065669141
Robert W Alexander, MD (SUB_INVESTIGATOR)

Find similar trials in Valencia, CA

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
Hemwall Center for Orthopedic Regenerative Medicine· Valencia, CARegenevita LLC· Stevensville, MT

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