Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis (GARM-MSK-ALD)

September 30, 2024 updated by: Healeon Medical Inc

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Osteoarthritis (OA) is one of the most common chronic health conditions and a leading cause of pain and disability in the world, with a substantial proportion of adults affected. It is estimated that symptomatic OA affects one in eight men and women in the US (27-31 million), In a global study of health conditions, osteoarthritis and musculoskeletal pain ranked in the top 4 percent of worldwide disabilities. OA is a complex, multifactorial disease, with much still to learn regarding mechanisms and progression. . The most commonly affected joints include the hip , knee , hand and foot , and spine. although OA can affect any joint. OA is linked to substantial economic costs estimated in developed countries to be between 1% and 2.5% of GDP. With the rise in life expectancy, the prevalence of osteoarthritis is projected to increase further, resulting in a greater healthcare burden.

Diagnosis is commonly accomplished via clinical examinations and subjective symptoms coupled with a variety of imaging protocols. These are an intrinsic portion of the protocols of this Trial, measuring both the safety and outcomes resulting from three basic approaches to provide both cellular and biocellular therapeutic approaches.

The Trial consists of three separate approaches: 1). Use of guided biocellular therapy (tSVF + Platelet Rich Plasma); 2). Use of guided biocellular and cellular therapy (tSVF + Platelet Rich Plasma + cSVF concentrates); and, 3). Use of cSVF only via systemic deployment suspended in sterile Normal Saline IV solution. Patient's will be enrolled based on the approach considered the most likely to safely attain clinical improvement and compared to others of similar findings in the same musculoskeletal indications.

Follow up and tracking to be extended over a two year period (minimum) following each treatment delivery. Those who do more than one site, or have a repeat treatment, will be followed on separate tracks to maintain the outcomes resulting from single versus double treatments. Management and voluntary enrollment will follow existing HIPPA (confidentiality) rules and regulations in place.

Participants will be requested to report any and all Adverse Events or Severe Adverse Events (complications not anticipated within parameters of usual and customary side effects resulting from such therapies) as may potentially result from any treatment provided (not including the normal "sequelae" of procedures utilized.

Cartilage loss remains the main pathologic features of OA, however OA is recognized to involve aging, inflammation and degenerative changes within the musculoskeletal joint, components, including pathologic changes in the bone, cartilage, and supportive soft tissues, As a natural process within aging and mechanical stresses, the ability of our homeostatic system to maintain a fully functional, pain free system, Weight bearing and repetitive trauma contribute to the demand for attempted repairs after use, it is common for OA to be found in multiple joints within the same individual over time and use.

Another aspect of OA is that it has been shown to be present in multiple joints in the same individual, suggesting a systemic bone response to mechanical stresses. When OA is severe, the bone involvement can be detected on plain radiographs, but radiographs may not detect milder cases. And while radiographs remain the standard means of diagnosing OA severity , these provide no information about the non-bone aspects of OA pathophysiology. Studies demonstrate that diagnostic musculoskeletal ultrasound as a complementary imaging tool, along with radiography, may enable more accurate diagnostics for osteoarthritis.

Treatments consist of harvesting (with microcannula) a small volume of tSVF to provide the needed stem/stromal cells found in large numbers around the small capillaries and blood vessels (needs typically 5-15 teaspoons). This tSVF is mixed with the patient's own concentrated platelets and guided for placement with use of a high resolution ultrasound for accurate placement. These elements are what are normally used in our bodies for maintaining (homeostasis) and repair (regenerative healing), with the advantage of accurate placement into the bone, soft tissues and joints involved in inflammatory or degenerative breakdown with pain and loss of function.

Each patient will be carefully followed to measure progress and imaging which documents structural changes that may be realized with these treatments. Of most note, the avoidance or postponement of invasive and often difficult rehabilitation is realized.

These procedures have been safely and successfully provided for approximately 15 years, however, without a large series and tracking over a period of years. We are seeking validation of the processes and elements which have been performed and reported in case reporting or small case series.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Valencia, California, United States, 91355
        • Recruiting
        • Hemwall Center for Orthopedic Regenerative Medicine
        • Contact:
    • Montana
      • Stevensville, Montana, United States, 59870
        • Not yet recruiting
        • Regenevita LLC
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Robert W Alexander, MD

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.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tSVF + PRP Arm1
Tissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) Concentrate
Procedure: Tissue Stromal Vascular Fraction (tSVF) Arm 1
Harvesting subcutaneous tSVF with sterile, disposable microcannula system
Biological: PRP Concentrate Arm 1
Preparation of PRP Concentrate via sterile Terumo-Harvest System
Experimental: tSVF + PRP + cSVF Arm 2
Tissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) Concentrate + Cellular Stromal Vascular Fraction (cSVF)
Procedure: Tissue Stromal Vascular Fraction (tSVF) Arm 2
Harvesting subcutaneous tSVF with sterile, disposable microcannula system
Biological: PRP Concentrate Arm 2
Preparation of PRP Concentrate via sterile Terumo-Harvest System
Procedure: Cellular Stromal Vascular Fraction (cSVF) Arm 2
Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)
Experimental: Normal Saline IV + cSVF Arm 3
Cellular Stromal Vascular Fraction (cSVF); Sterile Normal Saline Intravenous (IV) Introduction
Procedure: Cellular Stromal Vascular Fraction (cSVF) Arm 3
Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)
Drug: Sterile Normal Saline (IV Solution)
Suspension of cSVF in 500 cc Sterile Normal Saline (IV Solution)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Baseline; 6 Month; 1 year
Measure Knee and OA Status for Pain and OA
Baseline; 6 Month; 1 year
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: Baseline; 6 Month; 1 Year
Measure Change from Baseline of Pain and Arthritis In Knee and Hip
Baseline; 6 Month; 1 Year
Hip Disability and OA Outcomes Survey (HOOS)
Time Frame: Baseline; 6 Month; 1 Year
Measure Change from Baseline of Pain & Function of Hip
Baseline; 6 Month; 1 Year
Disabilities of the Arm, Shoulder, and Hand Score (DASH)
Time Frame: Baseline; 6 Month; 1 Year
Measure Change from Baseline of Pain, Range of Motion and Function All Areas
Baseline; 6 Month; 1 Year
Roland-Morris Back Pain Questionnaire (RMBPQ)
Time Frame: Baseline; 6 months; 1 year
Measure Change from Baseline of Pain, Function and Range of Motion
Baseline; 6 months; 1 year
Foot and Ankle Ability Measure (FAAM)
Time Frame: Baseline; 6 Month; 1 Year
Measure Change from Baseline Pain, Function, Range of Motion
Baseline; 6 Month; 1 Year
Foot and Ankle Disability Index (FADI)
Time Frame: Baseline; 6 Month; 1 Year
Measure Change in Disability From Baseline Pain, Function, Range of Motion
Baseline; 6 Month; 1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healeon Medical Inc

Collaborators

Donna Alderman, DO
Robert W. Alexander, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

January 10, 2020

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

January 19, 2020

First Posted (Actual)

January 23, 2020

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GARM-MSK-ALD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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