Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Healeon Medical Inc
• Collaborators: Donna Alderman, DO; Robert W. Alexander, MD; Terry, Glenn C., M.D.
• Treatments: Complement Factor H

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