Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT04238143

Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis

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

100

Participants Needed

2

Research Sites

402 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

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.

CONDITIONS

Official 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 according to 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 impairment preventing tolerance or understanding of procedures and follow-up
  • Known active cancer or currently receiving chemotherapy or radiation therapy
  • Pregnancy
  • Active infections increasing treatment risk
  • Use of high dose steroids or corticosteroids within six months before treatment
  • Medication or opiate addiction, or active drug rehabilitation treatment
  • History of severe traumatic brain injuries
  • Any medical condition that would prevent completing study requirements according to the principal investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

K

Kathy Cirricione, BS

CONTACT

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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