Recruiting

Adipose-Derived Therapy

Sponsor:

Healeon Medical Inc

Code:

NCT04238143

Conditions

Osteoarthritis

Osteo Arthritis Knee

Osteo Arthritis Shoulders

Osteoarthritis of Multiple Joints

Osteoarthritis, Hip

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tissue Stromal Vascular Fraction (tSVF) Arm 1

PRP Concentrate Arm 1

Tissue Stromal Vascular Fraction (tSVF) Arm 2

PRP Concentrate Arm 2

Cellular Stromal Vascular Fraction (cSVF) Arm 2

Study Details

Brief 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.

Conditions

Osteoarthritis

Osteo Arthritis Knee

Osteo Arthritis Shoulders

Osteoarthritis of Multiple Joints

Osteoarthritis, Hip

Study ID

NCT04238143

Start date

Jan 10, 2020

Status verified date

Sep, 2024

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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)

Primary outcome measure

  • Participant with Complications [ Time Frame: 6 Months ]
  • Numeric Pain Rating Scale (NPRS) [ Time Frame: 6 months ]
  • Changes from Baseline visual analog pain scale (VAS) [ Time Frame: Baseline, 1 month, 6 months, 1 year ]
  • Changes in Ultrasound Images from Baseline Condition [ Time Frame: Baseline, 6 months, 1 year ]

Central Contacts and Locations

Central contacts

Donna Alderman, DO

1 661 295 1110hemwallcenter@prolotherapy.com

Kathy Cirricione, BS

1 661 295 1110hemwallcenter@gmail.com

Locations

Hemwall Center for Orthopedic Regenerative Medicine

Recruiting

Valencia, California, United States, 91355

Contacts

Kelly Cirricone, BS

661-295-1110hemwallcenter@gmail.com

More Information

Sponsor

Healeon Medical Inc

Last update posted

Oct 1, 2024

Last verified

Sep, 2024

Keywords

  • Arthritis
  • Degenerative
  • Joint Disease
  • Rheumatoid Arthritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Healeon Medical Inc on 2024-10-01.