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Cellular & Biocellular Regenerative Therapy in Musculoskeletal Pain, Dysfunction,Degenerative or Inflammatory Disease (BRT)

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ClinicalTrials.gov Identifier: NCT03090672
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : August 24, 2018
Sponsor:
Collaborators:
Regeneris Medical
Global Alliance for Regenerative Medicine
Information provided by (Responsible Party):
Ryan Welter, MD, PhD, Regeneris Medical

Brief Summary:

Musculoskeletal disorders and degeneration represent injuries or pain in the body's joint ligaments, tendons, muscles, nerves, and skeletal elements that support extremities, spine and related tissues. Direct injuries and aging contribute to breakdown and inflammation of these tissues, leading to debilitation and loss of function in these areas. This has major impact on quality of life, occupational/recreation limitations, and psychosocial implications.

Many therapies have been employed including medications, physical therapy, occupational therapy, and a variety of surgical interventions each of which have distinct limitations, often covering the issues versus providing actual healing and return to function. Many reports are now available utilizing self-healing options which include use of stem/stromal cellular therapy or biocellular treatments (either from adipose or marrow) using targeted placement of cells, matrix and platelet concentrates. Termed cellular or Biocellular therapy (typically optimized using ultrasound guidance). It is proposed that use of cellular isolates or cell-stroma derived from the largest deposit of these cells (adipose greater than marrow), may use in conjunction with targeted placement or as a stand alone methodology intravascular use.

This study is designed as a interventional means to examine the safety and efficacy of the use of cellular and tissue stromal vascular fraction in musculoskeletal pain, dysfunction degeneration or inflammatory disorders.


Condition or disease Intervention/treatment Phase
Osteoarthritis Rheumatoid Nodule Degenerative Joint Disease Tendinopathy Tendinosis Back Pain Drug: Normal Saline Procedure: Tissue Stromal Vascular Fraction Biological: Platelet Rich Plasma Procedure: Cellular Stromal Vascular Fraction Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Cellular and Biocellular Therapy in Musculoskeletal Pain, Dysfunction, Degenerative or Inflammatory Disease
Actual Study Start Date : March 11, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: tSVF + PRP Arm1
Stromal Vascular Fraction tSVF + Platelet Rich Plasma (PRP) concentrate
Procedure: Tissue Stromal Vascular Fraction
tSVF

Biological: Platelet Rich Plasma
PRP

Experimental: tSVF + PRP + cSVF Enrichment Arm 2
tissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) concentration + (cSVF)
Procedure: Tissue Stromal Vascular Fraction
tSVF

Biological: Platelet Rich Plasma
PRP

Procedure: Cellular Stromal Vascular Fraction
cSVF

Experimental: Normal Saline IV + cSVF Arm 3
Cellular Stromal Vascular Fraction (cSVF); Normal Saline IV introduction
Drug: Normal Saline
Normal Saline IV delivery

Procedure: Cellular Stromal Vascular Fraction
cSVF




Primary Outcome Measures :
  1. Participants with complications [ Time Frame: 1 month ]
    Adverse and Severe Adverse Events Reports


Secondary Outcome Measures :
  1. Change from baseline quality of life level (QoL Questionnaire) [ Time Frame: 6 months, 12 months ]
    QoL Questionnaire

  2. Change from baseline visual analog pain score [ Time Frame: 6 months, 1 year, 2 year ]
    Changes of Visual Analog Pain Score (VAS) 1-10

  3. Change from baseline of limitation of activities (Functional analysis of range of motion) [ Time Frame: baseline, 6 months, 1 year ]
    Functional analysis of range of motion compared from baseline

  4. Change from baseline of imaging if required for study entry [ Time Frame: baseline, 1 year ]
    imaging



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:

  • Patients with documented inflammatory, autoimmune (rheumatoid arthritis (RA), degeneration of musculoskeletal system
  • No systemic disorders which, in the opinion of the principal investigators or provider, would disqualify from being safely able to undergo needed procedures
  • Able to provide informed consent
  • Patient having adequate donor adipose (fat) tissue
  • Patient mature enough to tolerate the needed procedures

Exclusion Criteria:

  • Systemic or psychological impairment which would preclude patient tolerance and understanding of procedures and follow up
  • Patients with known active cancer and chemotherapy or radiation therapy
  • Patients with ongoing active infections
  • High dose steroid users or use of injections of corticoid steroids within a six month timeframe
  • Opiate addition or in treatment program for withdrawal
  • History of severe traumatic brain injuries
  • If, in the opinion of providers, the patient will not be able to fully cooperate or complete the study and its follow up

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): NCT03090672


Contacts
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Contact: Ryan JP Welter, MD, PhD 508.345.5492 r.welter@regenerismedical.com
Contact: Gabrielle Lewis 508.316.4268 g.lewis@regenerismedical.com

Locations
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United States, Massachusetts
Regeneris Medical Recruiting
North Attleboro, Massachusetts, United States, 02760
Contact: Gabrielle Lewis    508-316-4268    g.lewis@regenerismedical.com   
Contact: Gabielle lEWIS    508/316.4268    g.lewis@regenerismedical.com   
Regeneris Medical Recruiting
North Attleboro, Massachusetts, United States, 02760
Contact: Ryan JP Welter, MD    508-345-5492    r.welter@regenerismedical.com   
Contact: Gabrielle Lewis    508.316.4268    g.lewis@regenerismedical.com   
Principal Investigator: Glenn C Terry, MD         
Principal Investigator: Robert W Alexander, MD         
Principal Investigator: Ryan JP Welter, MD,PhD         
Sponsors and Collaborators
Ryan Welter, MD, PhD
Regeneris Medical
Global Alliance for Regenerative Medicine
Investigators
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Principal Investigator: Robert W Alexander, MD GARM USA
Principal Investigator: Glenn C Terry, MD Global Alliance for Regenerative Medicine (GARM)
Principal Investigator: Ryan JP Welter, MD, PhD Regeneris Medical

Publications of Results:
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. Prolo; 2013; 5: e895-912.

Other Publications:
Alexander, Robert W., Understanding Mechanical Emulsification (NanoFat) Versus Enzymatic Isolation fo Tissue Stromal Vascular Fraction (tSVF) From Adipose Tissue: Potential Uses in Biocellular Regenerative Medicine. J of Prolo. 2016; 8: 3947-960.
Alderman, D, Alexander, R.W.,: Advances In Regenerative Medicine: High Density Platelet-Rich Plasma and Stem Cell Prolotherapy. J Pract Pain Management, 2011; Vol Oct: 49-90
Alexander, Robert W., Understanding Adipose-Derived Stromal Vascular Fraction (SVF) Cell Biology On The Basis of Perivascular Cell Components In Aesthetic and Regenerative Medicine. J. Prolo; 2012; 4: e13777
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). Clinical Cosmetic and Investigational Dermatology. 2013: 6: 91-102.

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Responsible Party: Ryan Welter, MD, PhD, Principal Investigator, Regeneris Medical
ClinicalTrials.gov Identifier: NCT03090672     History of Changes
Other Study ID Numbers: RGV MSK 1
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Comparative analysis of safety and efficacy between use of ultrasound guided tissue stromal vascular fraction (AD-tSVF) plus high density platelet rich plasma (HD-PRP) with use of intravascular deployment of adipose-derived cellular stromal vascular fraction (AD-cSVF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ryan Welter, MD, PhD, Regeneris Medical:
Arthritis
Degenerative
Tendinosis
Jont disease
Low back pain

Additional relevant MeSH terms:
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Osteoarthritis
Back Pain
Tendinopathy
Musculoskeletal Pain
Joint Diseases
Rheumatoid Nodule
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Tendon Injuries
Wounds and Injuries
Arthritis, Rheumatoid
Connective Tissue Diseases