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

NCT03090672 | Unknown DMC

• 1 other identifier: RGV MSK 1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis; Rheumatoid Nodule; Degenerative Joint Disease; Tendinopathy; Tendinosis; Back Pain

Keywords

Arthritis; Degenerative; Tendinosis; Jont disease; Low back pain

Outcome Measures

Primary Outcomes (1)

• Participants with complications

  Adverse and Severe Adverse Events Reports

  1 month

Secondary Outcomes (4)

• Change from baseline quality of life level (QoL Questionnaire)

  6 months, 12 months

• Change from baseline visual analog pain score

  6 months, 1 year, 2 year

• Change from baseline of limitation of activities (Functional analysis of range of motion)

  baseline, 6 months, 1 year

• Change from baseline of imaging if required for study entry

  baseline, 1 year

Study Arms (3)

tSVF + PRP Arm1

EXPERIMENTAL

Stromal Vascular Fraction tSVF + Platelet Rich Plasma (PRP) concentrate

Procedure: Tissue Stromal Vascular Fraction; Biological: Platelet Rich Plasma

tSVF + PRP + cSVF Enrichment Arm 2

EXPERIMENTAL

tissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) concentration + (cSVF)

Procedure: Tissue Stromal Vascular Fraction; Biological: Platelet Rich Plasma; Procedure: Cellular Stromal Vascular Fraction

Normal Saline IV + cSVF Arm 3

EXPERIMENTAL

Cellular Stromal Vascular Fraction (cSVF); Normal Saline IV introduction

Drug: Normal Saline; Procedure: Cellular Stromal Vascular Fraction

Interventions

Normal Saline DRUG

Normal Saline IV delivery

Normal Saline IV + cSVF Arm 3

Tissue Stromal Vascular Fraction PROCEDURE

tSVF

tSVF + PRP + cSVF Enrichment Arm 2; tSVF + PRP Arm1

Platelet Rich Plasma BIOLOGICAL

PRP

tSVF + PRP + cSVF Enrichment Arm 2; tSVF + PRP Arm1

Cellular Stromal Vascular Fraction PROCEDURE

cSVF

Normal Saline IV + cSVF Arm 3; tSVF + PRP + cSVF Enrichment Arm 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Robert W Alexander, MD: lead
• Regeneris Medical: collaborator
• Global Alliance for Regenerative Medicine: collaborator

Study Sites (2)

Regeneris Medical

North Attleboro, Massachusetts, 02760, United States

RECRUITING

Regeneris Medical

North Attleboro, Massachusetts, 02760, United States

RECRUITING

Related Publications (12)

• Kuorinka I, Jonsson B, Kilbom A, Vinterberg H, Biering-Sorensen F, Andersson G, Jorgensen K. Standardised Nordic questionnaires for the analysis of musculoskeletal symptoms. Appl Ergon. 1987 Sep;18(3):233-7. doi: 10.1016/0003-6870(87)90010-x.

  PMID: 15676628 BACKGROUND

• Gallagher S, Heberger JR. Examining the interaction of force and repetition on musculoskeletal disorder risk: a systematic literature review. Hum Factors. 2013 Feb;55(1):108-24. doi: 10.1177/0018720812449648.

  PMID: 23516797 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 27788905 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 23630430 BACKGROUND

• 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.

  PMID: 24387819 BACKGROUND

• 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.

  PMID: 24792949 BACKGROUND

• 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.

  PMID: 26080045 BACKGROUND

• 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.

  PMID: 22925619 BACKGROUND

• 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.

  RESULT

MeSH Terms

Conditions

Osteoarthritis; Rheumatoid Nodule; Joint Diseases; Tendinopathy; Back Pain; Arthritis; Low Back Pain

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Rheumatic Diseases; Arthritis, Rheumatoid; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Muscular Diseases; Tendon Injuries; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan JP Welter, MD, PhD

CONTACT

508.345.5492; r.welter@regenerismedical.com

Gabrielle Lewis

CONTACT

508.316.4268; g.lewis@regenerismedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 27, 2017
• Study Start: March 11, 2017
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2022
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (2)