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OsteoarthritisGARM-MSK-ALDNCT04238143

Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis

A study testing Tissue Stromal Vascular Fraction (tSVF) Arm 1, PRP Concentrate Arm 1 and Tissue Stromal Vascular Fraction (tSVF) Arm 2 in people with Osteoarthritis and Osteo Arthritis Knee, run by Healeon Medical Inc at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Tissue Stromal Vascular Fraction (tSVF) Arm 1, PRP Concentrate Arm 1 and Tissue Stromal Vascular Fraction (tSVF) Arm 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesUnited States
Study dates
10 Jan 2020to 30 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Donna Alderman, DO contact

1 661 295 1110

hemwallcenter@prolotherapy.com

Kathy Cirricione, BS contact

1 661 295 1110

hemwallcenter@gmail.com

United States2 sites, 2 recruiting

  • Regenevita LLC

    Stevensville, Montana, 59870

    Glenn C Terry, MD, 706-566-9141, corky3444@gmail.com

    Heather Terry, 17065669141, info@garm.com.hn

    Not yet recruiting

  • Hemwall Center for Orthopedic Regenerative Medicine

    Valencia, California, 91355

    Kelly Cirricone, BS, 661-295-1110, hemwallcenter@gmail.com

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Tissue Stromal Vascular Fraction (tSVF) Arm 1, PRP Concentrate Arm 1, Tissue Stromal Vascular Fraction (tSVF) Arm 2, PRP Concentrate Arm 2, Cellular Stromal Vascular Fraction (cSVF) Arm 2
Keywords
Arthritis, Degenerative, Joint Disease, Rheumatoid Arthritis
Medical subject headings
Osteoarthritis, Osteoarthritis, Hip, Arthritis, Joint Diseases, Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tissue Stromal Vascular Fraction (tSVF) Arm 1Procedure or surgery

    Harvesting subcutaneous tSVF with sterile, disposable microcannula system

  • PRP Concentrate Arm 1Biological

    Preparation of PRP Concentrate via sterile Terumo-Harvest System

  • Tissue Stromal Vascular Fraction (tSVF) Arm 2Procedure or surgery

    Harvesting subcutaneous tSVF with sterile, disposable microcannula system

  • PRP Concentrate Arm 2Biological

    Preparation of PRP Concentrate via sterile Terumo-Harvest System

  • Cellular Stromal Vascular Fraction (cSVF) Arm 2Procedure or surgery

    Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)

  • Cellular Stromal Vascular Fraction (cSVF) Arm 3Procedure or surgery

    Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)

  • Sterile Normal Saline (IV Solution)Drug

    Suspension of cSVF in 500 cc Sterile Normal Saline (IV Solution)

Study groups in NCT04238143
Study groupRoleWhat they receive
tSVF + PRP Arm1ExperimentalTissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) Concentrate
Receives: Procedure: Tissue Stromal Vascular Fraction (tSVF) Arm 1; Biological: PRP Concentrate Arm 1
tSVF + PRP + cSVF Arm 2ExperimentalTissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) Concentrate + Cellular Stromal Vascular Fraction (cSVF)
Receives: Procedure: Tissue Stromal Vascular Fraction (tSVF) Arm 2; Biological: PRP Concentrate Arm 2; Procedure: Cellular Stromal Vascular Fraction (cSVF) Arm 2
Normal Saline IV + cSVF Arm 3ExperimentalCellular Stromal Vascular Fraction (cSVF); Sterile Normal Saline Intravenous (IV) Introduction
Receives: Procedure: Cellular Stromal Vascular Fraction (cSVF) Arm 3; Drug: Sterile Normal Saline (IV Solution)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participant with Complications

    Adverse and Severe Adverse Events

    Measured: 6 Months

  2. Numeric Pain Rating Scale (NPRS)

    Subjective Pain Rating

    Measured: 6 months

  3. Changes from Baseline visual analog pain scale (VAS)

    Patient Reported Pain (1-10)

    Measured: Baseline, 1 month, 6 months, 1 year

  4. Changes in Ultrasound Images from Baseline Condition

    High Definition Ultrasonography Soft and Hard Tissues of Musculoskeletal Areas To Be Treated

    Measured: Baseline, 6 months, 1 year

Secondary outcomes (7)

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Measure Knee and OA Status for Pain and OA

    Measured: Baseline; 6 Month; 1 year

  2. Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Measure Change from Baseline of Pain and Arthritis In Knee and Hip

    Measured: Baseline; 6 Month; 1 Year

  3. Hip Disability and OA Outcomes Survey (HOOS)

    Measure Change from Baseline of Pain \& Function of Hip

    Measured: Baseline; 6 Month; 1 Year

  4. Disabilities of the Arm, Shoulder, and Hand Score (DASH)

    Measure Change from Baseline of Pain, Range of Motion and Function All Areas

    Measured: Baseline; 6 Month; 1 Year

  5. Roland-Morris Back Pain Questionnaire (RMBPQ)

    Measure Change from Baseline of Pain, Function and Range of Motion

    Measured: Baseline; 6 months; 1 year

  6. Foot and Ankle Ability Measure (FAAM)

    Measure Change from Baseline Pain, Function, Range of Motion

    Measured: Baseline; 6 Month; 1 Year

  7. Foot and Ankle Disability Index (FADI)

    Measure Change in Disability From Baseline Pain, Function, Range of Motion

    Measured: Baseline; 6 Month; 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2020
  2. Study start10 Jan 2020
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04238143
Sponsor's protocol ID
GARM-MSK-ALD
Acronym
GARM-MSK-ALD
Status last verified
Sep 2024
First submitted
13 Jan 2020
Last updated
1 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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 RW, Harrell DB. Autologous fat grafting: use of closed syringe microcannula system for enhanced autologous structural grafting. Clin Cosmet Investig Dermatol. 2013 Apr 8;6:91-102. doi: 10.2147/CCID.S40575. Print 2013.

    PubMed 23630430

  • Albano JJ, Alexander RW. Autologous fat grafting as a mesenchymal stem cell source and living bioscaffold in a patellar tendon tear. Clin J Sport Med. 2011 Jul;21(4):359-61. doi: 10.1097/JSM.0b013e31821d0864. No abstract available.

    PubMed 21562415

  • Lin, K., Short Review on the advancement of osteoarthritis treatment with cell therapy. J. Regen Biol Med. (2020), 2(1): 1-7.

  • Mehranfar S, Abdi Rad I, Mostafav E, Akbarzadeh A. The use of stromal vascular fraction (SVF), platelet-rich plasma (PRP) and stem cells in the treatment of osteoarthritis: an overview of clinical trials. Artif Cells Nanomed Biotechnol. 2019 Dec;47(1):882-890. doi: 10.1080/21691401.2019.1576710.

    PubMed 30887856

  • Hong Z, Chen J, Zhang S, Zhao C, Bi M, Chen X, Bi Q. Intra-articular injection of autologous adipose-derived stromal vascular fractions for knee osteoarthritis: a double-blind randomized self-controlled trial. Int Orthop. 2019 May;43(5):1123-1134. doi: 10.1007/s00264-018-4099-0. Epub 2018 Aug 14.

    PubMed 30109404

  • Alderman, D. Regenerative injection therapies for pain: traditional, platelet-rich plasma, and biocellular prolotherapy. text, 345, 2016.

  • Alexander RW. Biocellular Regenerative Medicine: Use of Adipose-Derived Stem/Stromal Cells and It's Native Bioactive Matrix. Phys Med Rehabil Clin N Am. 2016 Nov;27(4):871-891. doi: 10.1016/j.pmr.2016.06.005.

    PubMed 27788905

  • Nelson AE, Allen KD, Golightly YM, Goode AP, Jordan JM. A systematic review of recommendations and guidelines for the management of osteoarthritis: The chronic osteoarthritis management initiative of the U.S. bone and joint initiative. Semin Arthritis Rheum. 2014 Jun;43(6):701-12. doi: 10.1016/j.semarthrit.2013.11.012. Epub 2013 Dec 4.

    PubMed 24387819

  • 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.

  • Burdett N, McNeil JD. Difficulties with assessing the benefit of glucosamine sulphate as a treatment for osteoarthritis. Int J Evid Based Healthc. 2012 Sep;10(3):222-6. doi: 10.1111/j.1744-1609.2012.00279.x.

    PubMed 22925619

  • Thorlund JB, Juhl CB, Roos EM, Lohmander LS. Arthroscopic surgery for degenerative knee: systematic review and meta-analysis of benefits and harms. BMJ. 2015 Jun 16;350:h2747. doi: 10.1136/bmj.h2747.

    PubMed 26080045

  • Katz JN, Brownlee SA, Jones MH. The role of arthroscopy in the management of knee osteoarthritis. Best Pract Res Clin Rheumatol. 2014 Feb;28(1):143-56. doi: 10.1016/j.berh.2014.01.008.

    PubMed 24792949

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Tissue Stromal Vascular Fraction (tSVF) Arm 1, PRP Concentrate Arm 1 and Tissue Stromal Vascular Fraction (tSVF) Arm 2 in people with Osteoarthritis and Osteo Arthritis Knee, run by Healeon Medical Inc at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Donna Alderman, DO (1 661 295 1110, hemwallcenter@prolotherapy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant with Complications (time frame: 6 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04238143, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.

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GARM-MSK-ALD Clinical Trial NCT04238143 | AzTrials