Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis

This study is exploring new ways to treat osteoarthritis (OA) in the knee, hip, shoulder, and other joints using your body's own cells. Researchers are testing two main approaches: one uses Tissue Stromal Vascular Fraction (tSVF) combined with PRP Concentrate, and the other uses tSVF, PRP Concentrate, and Cellular Stromal Vascular Fraction (cSVF). These treatments aim to reduce pain and improve function without traditional surgery or medications. The study will enroll about 100 adults, aged 18 to 90, who have documented osteoarthritis. Success will be measured by how much your pain changes and if there are any complications over 6 months to 1 year.

Study design: This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 100 participants.
What's involved: You would undergo procedures to harvest cells and prepare concentrates, followed by the treatment itself. Your pain levels will be measured at baseline, 1 month, 6 months, and 1 year.
Compensation: Not stated in the trial record.
Follow-up: Your progress will be tracked for up to 1 year after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis

Recruiting

NAAges 18–90InterventionalTreatment

Healeon Medical Inc

~100 participants

Updated 2024-10-01 on ClinicalTrials.gov

What's tested:Tissue Stromal Vascular Fraction (tSVF) Arm 1PRP Concentrate Arm 1Tissue Stromal Vascular Fraction (tSVF) Arm 2PRP Concentrate Arm 2Cellular Stromal Vascular Fraction (cSVF) Arm 2Cellular Stromal Vascular Fraction (cSVF) Arm 3

At a glance

Recruiting sites

1 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Participant with Complications

Measured over 6 Months

+3 more outcomes measured

Conditions

Osteoarthritis

Osteo Arthritis Knee

Osteo Arthritis Shoulders

Osteoarthritis of Multiple Joints

Osteoarthritis, Hip

Osteoarthritis - Ankle/Foot

Where it's being run

2 sites across 2 states

California1

Montana1

Who to contact

Donna Alderman, DO

[email protected]

1 661 295 1110

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

Participant with Complications6 Months
Adverse and Severe Adverse Events
Numeric Pain Rating Scale (NPRS)6 months
Subjective Pain Rating
Changes from Baseline visual analog pain scale (VAS)Baseline, 1 month, 6 months, 1 year
Patient Reported Pain (1-10)
Changes in Ultrasound Images from Baseline ConditionBaseline, 6 months, 1 year
High Definition Ultrasonography Soft and Hard Tissues of Musculoskeletal Areas To Be Treated

Trialytics