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Testing a patient's own stem cells and platelet-rich plasma for osteoarthritis

Tests a patient's own fat-derived cells with plasma treatment in people with osteoarthritis.

Key facts

Who runs it
Healeon Medical Inc
Where
Stevensville and Valencia, United StatesSee the 2 sites
Trial code
Registry title
Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis
Status
Recruiting
People taking part
100 people, planned
Started
10 Jan 2020
Expected to end
30 Sept 2027
Type of study
Interventional, 3 groups
Treatments tested
  • 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
  • Cellular Stromal Vascular Fraction (cSVF) Arm 3
  • Sterile Normal Saline (IV Solution)
Record updated
1 October 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with osteoarthritis or degenerative changes in joints or connective tissue. It tests treatment made from the person's own fat cells plus platelet-rich plasma (HD-PRP).

Age
18 to 90 years
Sex
All sexes can join.
Disease stage
Documented osteoarthritic inflammatory and/or degenerative changes in the knee, hip, shoulder, Achilles tendon, Sacroiliac Joint, wrist/hand, foot/ankle, or Plantar Fasciitis.
Earlier treatment
Cannot join if they had corticosteroids within six months before treatment or use high dose steroids.

Main reasons for not taking part

  • Known active cancer, chemotherapy, or radiation therapy
  • Pregnancy
  • Active infections that raise the risk of treatment
  • High dose steroid use, or corticosteroids within six months before treatment
  • Medication or opiate addiction, or being in drug rehabilitation

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • Active infections which would increase risk of patient to undergo treatment
  • 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
  • Pregnancy

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 90 years old?

Where in United States

  • Regenevita LLCStevensville, United StatesContact: Glenn C Terry, MDNot yet recruiting
  • Hemwall Center for Orthopedic Regenerative MedicineValencia, United StatesContact: Kelly Cirricone, BSTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 3 groups in the trial

  • tSVF + PRP Arm1Treatment being tested

    Tissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) Concentrate

    Treatment: Tissue Stromal Vascular Fraction (tSVF) Arm 1 and PRP Concentrate Arm 1

  • tSVF + PRP + cSVF Arm 2Treatment being tested

    Tissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) Concentrate + Cellular Stromal Vascular Fraction (cSVF)

    Treatment: Tissue Stromal Vascular Fraction (tSVF) Arm 2, PRP Concentrate Arm 2, and Cellular Stromal Vascular Fraction (cSVF) Arm 2

  • Normal Saline IV + cSVF Arm 3Treatment being tested

    Cellular Stromal Vascular Fraction (cSVF); Sterile Normal Saline Intravenous (IV) Introduction

    Treatment: Cellular Stromal Vascular Fraction (cSVF) Arm 3 and Sterile Normal Saline (IV Solution)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Adipose-Derived Biocellular Regenerative Therapy in Treatment of Osteoarthritis (OA) and Associated Connective Tissue Degeneration and Pain
Plain-language title
Testing a patient's own stem cells and platelet-rich plasma for osteoarthritisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04238143, who can take part
Record updated
1 October 2024