Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorHealeon Medical Inc

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • 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)

Treatment groups

100 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Healeon Medical Inc

Lead sponsor

Donna Alderman, DO

Collaborator

Robert W. Alexander, MD

Collaborator