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Clinical Trials in the USA / NCT04238143
Recruiting Not applicable

Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis

NCT04238143 · tracked via the Priya Life Science USA tracker
Sponsor
Healeon Medical Inc
Phase
Not applicable
Started
2020-01-10
Last updated
2024-10-01

Condition(s) studied

OsteoarthritisOsteo Arthritis KneeOsteo Arthritis ShouldersOsteoarthritis of Multiple JointsOsteoarthritis, HipOsteoarthritis - Ankle/Foot

Investigational drug(s) / intervention(s)

Tissue Stromal Vascular Fraction (tSVF) Arm 1PRP Concentrate Arm 1Tissue Stromal Vascular Fraction (tSVF) Arm 2PRP Concentrate Arm 2Cellular Stromal Vascular Fraction (cSVF) Arm 2Cellular Stromal Vascular Fraction (cSVF) Arm 3Sterile Normal Saline (IV Solution)

Tissue Stromal Vascular Fraction (tSVF) Arm 1: Harvesting subcutaneous tSVF with sterile, disposable microcannula system

PRP Concentrate Arm 1: Preparation of PRP Concentrate via sterile Terumo-Harvest System

Tissue Stromal Vascular Fraction (tSVF) Arm 2: Harvesting subcutaneous tSVF with sterile, disposable microcannula system

PRP Concentrate Arm 2: Preparation of PRP Concentrate via sterile Terumo-Harvest System

Cellular Stromal Vascular Fraction (cSVF) Arm 2: Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)

Cellular Stromal Vascular Fraction (cSVF) Arm 3: Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)

Sterile Normal Saline (IV Solution): Suspension of cSVF in 500 cc Sterile Normal Saline (IV Solution)

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * Documented osteoarthritic inflammatory and/or degenerative changes in the joint or connective tissues of the knee, hip, shoulder, Achilles tendon, Sacroiliac Joint, wrist/hand, foot/ankle, or Plantar Fasciitis (PR); * No systemic disorders which, in opinion of principal investigator, would disqualify from safely being able to undergo the determined procedures; * Have the ability to understand and accept all items in Informed Consent Document; * Have adequate perivascular and extracellular matrix donor tissues available; * Mature enough to tolerate determined procedures and follow up instructions and complete post-treatment tracking responsibilities Exclusion Criteria: * Systemic or psychological impairment which would preclude patient tolerance and understanding nature and extent of procedures and follow up tracking; * Known active cancer, chemotherapy, or radiation therapy; * Pregnancy; * Active infections which would increase risk of patient to undergo treatment; * High dose steroid users, or recipients of corticosteroids with a six month period before treatment date; * Medication or Opiate addition, or in active treatment for drug rehabilitation; * History of documented severe traumatic brain injuries; * In the opinion of the principal investigator/provider, the patient's condition or medical issues which would not allow the individual to fully accomplish or complete the study requirements

Primary outcome measure(s)

  • Participant with Complications — 6 Months
    Adverse and Severe Adverse Events
  • Numeric Pain Rating Scale (NPRS) — 6 months
    Subjective Pain Rating
  • Changes from Baseline visual analog pain scale (VAS) — Baseline, 1 month, 6 months, 1 year
    Patient Reported Pain (1-10)
  • Changes in Ultrasound Images from Baseline Condition — Baseline, 6 months, 1 year
    High Definition Ultrasonography Soft and Hard Tissues of Musculoskeletal Areas To Be Treated

Trial sites (2)

FacilityCityRegionStatus
Hemwall Center for Orthopedic Regenerative Medicine Valencia California Recruiting
Regenevita LLC Stevensville Montana Not Yet Recruiting

Other trials for the same condition

A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee Active, not recruiting
Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Hip Recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization Active, not recruiting
Microfragmented Adipose Tissue Compared to Saline Injection for the Treatment of Knee Osteoarthritis Active, not recruiting
Exactech Shoulder Post Market Clinical Follow-up Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04238143 on ClinicalTrials.gov ↗ ← All trials in the USA