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

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ClinicalTrials.gov Identifier: NCT04238143
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : February 16, 2021
Sponsor:
Collaborators:
Donna Alderman, DO
Robert W. Alexander, MD
Information provided by (Responsible Party):
Healeon Medical Inc

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis Osteo Arthritis Knee Osteo Arthritis Shoulders Osteoarthritis of Multiple Joints Osteoarthritis, Hip Osteoarthritis - Ankle/Foot Procedure: Tissue Stromal Vascular Fraction (tSVF) Arm 1 Biological: PRP Concentrate Arm 1 Procedure: Tissue Stromal Vascular Fraction (tSVF) Arm 2 Biological: PRP Concentrate Arm 2 Procedure: Cellular Stromal Vascular Fraction (cSVF) Arm 2 Procedure: Cellular Stromal Vascular Fraction (cSVF) Arm 3 Drug: Sterile Normal Saline (IV Solution) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adipose-Derived Biocellular Regenerative Therapy in Treatment of Osteoarthritis (OA) and Associated Connective Tissue Degeneration and Pain
Actual Study Start Date : January 10, 2020
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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)




Primary Outcome Measures :
  1. Participant with Complications [ Time Frame: 6 Months ]
    Adverse and Severe Adverse Events

  2. Numeric Pain Rating Scale (NPRS) [ Time Frame: 6 months ]
    Subjective Pain Rating

  3. Changes from Baseline visual analog pain scale (VAS) [ Time Frame: Baseline, 1 month, 6 months, 1 year ]
    Patient Reported Pain (1-10)

  4. 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


Secondary Outcome Measures :
  1. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline; 6 Month; 1 year ]
    Measure Knee and OA Status for Pain and OA

  2. 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

  3. Hip Disability and OA Outcomes Survey (HOOS) [ Time Frame: Baseline; 6 Month; 1 Year ]
    Measure Change from Baseline of Pain & Function of Hip

  4. 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

  5. Roland-Morris Back Pain Questionnaire (RMBPQ) [ Time Frame: Baseline; 6 months; 1 year ]
    Measure Change from Baseline of Pain, Function and Range of Motion

  6. Foot and Ankle Ability Measure (FAAM) [ Time Frame: Baseline; 6 Month; 1 Year ]
    Measure Change from Baseline Pain, Function, Range of Motion

  7. Foot and Ankle Disability Index (FADI) [ Time Frame: Baseline; 6 Month; 1 Year ]
    Measure Change in Disability From Baseline Pain, Function, Range of Motion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04238143


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

Locations
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United States, California
Hemwall Center for Orthopedic Regenerative Medicine Recruiting
Valencia, California, United States, 91355
Contact: Kelly Cirricone, BS    661-295-1110    hemwallcenter@gmail.com   
United States, Montana
Regenevita LLC Not yet recruiting
Stevensville, Montana, United States, 59870
Contact: Glenn C Terry, MD    706-566-9141    corky3444@gmail.com   
Contact: Heather Terry    17065669141    info@garm.com.hn   
Sub-Investigator: Robert W Alexander, MD         
Sponsors and Collaborators
Healeon Medical Inc
Donna Alderman, DO
Robert W. Alexander, MD
Publications of Results:
Alderman, D, Alexander, RW, Stem Cell Prolotherapy In Regenerative Medicine: Background, Theory, and Protocols. J. Prolo 3(3): 689-708, 2011.
Alexander, RW, Overview of Cellular Stromal Vascular Fraction (cSVF) & Biocellular Uses of Stem/Stromal Cells & Matrix (tSVF + HD-PRP) in Regenerative Medicine, Aesthetic Medicine, and Plastic Surgery. J Stem Cell Res Ther; S1003, 2019.
Alderman, D, Alexander, RW. Advances In Regenerative Medicine: High Density Platelet-Rich Plasma and Stem Cell Prolotherapy. J. Prac Pain Management, Oct: 49-60, 2011.
Alexander, RW. Understanding Adipose-Derived Stromal Vascular Fraction (SVF) Cell Biology On The Basis of Perivascular Cell Components In Aesthetic & Regenerative Medicine. J. Prolo, 4: e13777, 2012.

Other Publications:
Oliver, K., Alexander, RW. Combination of Autologous Adipose-Derived Tissue Stromal Vascular Fraction Plus High Density Platelet-Rich Plasma or Bone Marrow Concentrates in Achilles Tendon Tears. J. Prolotherapy; 5:e895-912, 2013.
Alexander, Robert W., Use of Disposable Microcannula System For Low Pressure Harvest, Preparation, and Placement of Small Volume Autologous Fat Grafting With Activated High Density Platelet-Rich Plasma (HD-PRP). Clin Cosm Invest Derm 6:91-102, 2013.
Lin, K., Short Review on the advancement of osteoarthritis treatment with cell therapy. J. Regen Biol Med. (2020), 2(1): 1-7.
Alderman, D. Regenerative injection therapies for pain: traditional, platelet-rich plasma, and biocellular prolotherapy. text, 345, 2016.

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Responsible Party: Healeon Medical Inc
ClinicalTrials.gov Identifier: NCT04238143    
Other Study ID Numbers: GARM-MSK-ALD
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Healeon Medical Inc:
Arthritis
Degenerative
Joint Disease
Rheumatoid Arthritis
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Osteoarthritis, Hip
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Complement Factor H
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs