Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID04238143

Adipose-Derived Biocellular Regenerative Therapy in Treatment of Osteoarthritis and Connective Tissue Degeneration and Pain

Led by Healeon Medical Inc · Updated on 2024-10-01

100

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

Sponsors

H

Healeon Medical Inc

Lead Sponsor

D

Donna Alderman, DO

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of biocellular and cellular therapies derived from a person's own stem/stromal cells combined with platelet-rich plasma (PRP) to treat osteoarthritis (OA) and related musculoskeletal aging, pain, and degeneration. This study aims to explore minimally invasive, non-pharmaceutical treatments to relieve OA symptoms and improve joint function, addressing the limitations of traditional surgeries and medical management. The study tracks baseline health and monitors progress over time to understand treatment impact. The trial includes three treatment approaches: 1) guided biocellular therapy using tissue stromal vascular fraction (tSVF) plus PRP concentrate; 2) combined biocellular and cellular therapy with tSVF, PRP, and cellular stromal vascular fraction (cSVF); and 3) cSVF delivered intravenously suspended in sterile normal saline. Treatments involve harvesting stem cells and platelets, guided placement with ultrasound, and systemic infusion. Participants receive one or more treatments, with follow-up tracking to compare outcomes from single versus multiple sites or treatments. Participants will undergo regular assessments including imaging with ultrasound and radiography, pain scales, and joint function questionnaires at baseline, 1 month, 6 months, and up to 2 years post-treatment. Researchers monitor complications, pain changes, and structural joint improvements while participants report any unexpected adverse events. The trial includes long-term follow-up to assess safety and effectiveness of these regenerative therapies for OA and connective tissue degeneration.

CONDITIONS

Brief Title

Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • No systemic disorders that would prevent safe participation as determined by the principal investigator
  • Ability to understand and accept all items in the informed consent document
  • Adequate perivascular and extracellular matrix donor tissues available
  • Mature enough to tolerate procedures, follow up instructions, and complete post-treatment tracking
Not Eligible

You will not qualify if you...

  • Systemic or psychological impairments that prevent tolerance or understanding of procedures and follow up
  • Known active cancer or undergoing chemotherapy or radiation therapy
  • Pregnancy
  • Active infections that increase treatment risk
  • Use of high dose steroids or corticosteroids within six months before treatment
  • Medication or opiate addiction or active drug rehabilitation
  • History of severe traumatic brain injuries
  • Medical conditions that would prevent completing study requirements as judged by the principal investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment session

Participants receive one of three regenerative therapy approaches involving harvesting and preparation of cellular and biocellular products, which are then guided into affected joints or delivered intravenously.

1 treatment visit (in-person)

Follow-up

Duration - Minimum 2 years

Participants are followed and monitored over a minimum of two years to track progress, adverse events, and imaging changes after treatment.

Visits at baseline, 1 month, 6 months, 1 year, and ongoing follow-ups up to 2 years

Trial Site Locations

Total: 2 locations

1

Hemwall Center for Orthopedic Regenerative Medicine

Valencia, California, United States, 91355

Actively Recruiting

2

Regenevita LLC

Stevensville, Montana, United States, 59870

Not Yet Recruiting

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Research Team

D

Donna Alderman, DO

K

Kathy Cirricione, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Frequently Asked Questions

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Published Research Related To This Trial

The use of stromal vascular fraction (SVF), platelet-rich plasma (PRP) and stem cells in the treatment of osteoarthritis: an overview of clinical trials.

Sahar Mehranfar, Isa Abdi Rad, Ebrahim Mostafav...

https://pubmed.ncbi.nlm.nih.gov/30887856

Intra-articular injection of autologous adipose-derived stromal vascular fractions for knee osteoarthritis: a double-blind randomized self-controlled trial.

Zheping Hong, Jihang Chen, Shuijun Zhang...

https://pubmed.ncbi.nlm.nih.gov/30109404

A systematic review of recommendations and guidelines for the management of osteoarthritis: The chronic osteoarthritis management initiative of the U.S. bone and joint initiative.

Amanda E Nelson, Kelli D Allen, Yvonne M Golightly...

https://pubmed.ncbi.nlm.nih.gov/24387819