RECRUITING

Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Adipose-Derived Biocellular Regenerative Therapy in Treatment of Osteoarthritis (OA) and Associated Connective Tissue Degeneration and Pain

Quick Facts

Study Start:2020-01-10
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04238143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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);
  2. * No systemic disorders which, in opinion of principal investigator, would disqualify from safely being able to undergo the determined procedures;
  3. * Have the ability to understand and accept all items in Informed Consent Document;
  4. * Have adequate perivascular and extracellular matrix donor tissues available;
  5. * Mature enough to tolerate determined procedures and follow up instructions and complete post-treatment tracking responsibilities
  1. * Systemic or psychological impairment which would preclude patient tolerance and understanding nature and extent of procedures and follow up tracking;
  2. * Known active cancer, chemotherapy, or radiation therapy;
  3. * Pregnancy;
  4. * Active infections which would increase risk of patient to undergo treatment;
  5. * High dose steroid users, or recipients of corticosteroids with a six month period before treatment date;
  6. * Medication or Opiate addition, or in active treatment for drug rehabilitation;
  7. * History of documented severe traumatic brain injuries;
  8. * 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

Contacts and Locations

Study Contact

Donna Alderman, DO
CONTACT
1 661 295 1110
hemwallcenter@prolotherapy.com
Kathy Cirricione, BS
CONTACT
1 661 295 1110
hemwallcenter@gmail.com

Study Locations (Sites)

Hemwall Center for Orthopedic Regenerative Medicine
Valencia, California, 91355
United States
Regenevita LLC
Stevensville, Montana, 59870
United States

Collaborators and Investigators

Sponsor: Healeon Medical Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-10
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2020-01-10
Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

  • Arthritis
  • Degenerative
  • Joint Disease
  • Rheumatoid Arthritis

Additional Relevant MeSH Terms

  • Osteoarthritis
  • Osteo Arthritis Knee
  • Osteo Arthritis Shoulders
  • Osteoarthritis of Multiple Joints
  • Osteoarthritis, Hip
  • Osteoarthritis - Ankle/Foot