Clinical trial NCT04238143: Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis
Official title: Adipose-Derived Biocellular Regenerative Therapy in Treatment of Osteoarthritis (OA) and Associated Connective Tissue Degeneration and Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis
Osteo Arthritis Knee
Osteo Arthritis Shoulders
Osteoarthritis of Multiple Joints
Osteoarthritis, Hip
Osteoarthritis - Ankle/Foot
Keywords: Arthritis
Degenerative
Joint Disease
Rheumatoid Arthritis
Lead sponsor: Healeon Medical Inc
Sponsor class: INDUSTRY
Collaborators: name: Donna Alderman, DO
name: Robert W. Alexander, MD
First posted: 2020-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Participant with Complications
timeFrame: 6 Months
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 6 months
measure: Changes from Baseline visual analog pain scale (VAS)
timeFrame: Baseline, 1 month, 6 months, 1 year
measure: Changes in Ultrasound Images from Baseline Condition
timeFrame: Baseline, 6 months, 1 year
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline; 6 Month; 1 year
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: Baseline; 6 Month; 1 Year
measure: Hip Disability and OA Outcomes Survey (HOOS)
timeFrame: Baseline; 6 Month; 1 Year
measure: Disabilities of the Arm, Shoulder, and Hand Score (DASH)
timeFrame: Baseline; 6 Month; 1 Year
measure: Roland-Morris Back Pain Questionnaire (RMBPQ)
timeFrame: Baseline; 6 months; 1 year
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: Baseline; 6 Month; 1 Year
measure: Foot and Ankle Disability Index (FADI)
timeFrame: Baseline; 6 Month; 1 Year
Other outcomes:
Locations:
city: Valencia
country: United States
facility: Hemwall Center for Orthopedic Regenerative Medicine
state: California
city: Stevensville
country: United States
facility: Regenevita LLC
state: Montana
Study officials:
References:
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