Actively Recruiting
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
Eligibility Criteria
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
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
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
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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