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Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis

Healeon Medical Inc · with Donna Alderman, DO, Alexander, Robert W., M.D. · NCT04238143

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–90 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
100
US sites recruiting
1
Study start
January 10, 2020
Record last updated
October 1, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: 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)

Conditions: Osteoarthritis; Osteo Arthritis Knee; Osteo Arthritis Shoulders; Osteoarthritis of Multiple Joints; Osteoarthritis, Hip; Osteoarthritis - Ankle/Foot

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Hemwall Center for Orthopedic Regenerative Medicine

    Valencia, CA 91355

    Site contact: Kelly Cirricone, BS · 661-295-1110 · hemwallcenter@gmail.com

Study contacts (from the official record)

  • Donna Alderman, DO · 1 661 295 1110 · hemwallcenter@prolotherapy.com
  • Kathy Cirricione, BS · 1 661 295 1110 · hemwallcenter@gmail.com
All arthritis studies in California →
Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis (NCT04238143) | Bored Studies