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

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

Interventions

DRUG

Normal Saline

Normal Saline IV delivery

PROCEDURE

Tissue Stromal Vascular Fraction

tSVF

BIOLOGICAL

Platelet Rich Plasma

PRP

PROCEDURE

Cellular Stromal Vascular Fraction

cSVF

Sponsors & Collaborators

• Regeneris Medical

  collaborator OTHER

• Global Alliance for Regenerative Medicine

  collaborator OTHER

• Robert W Alexander, MD

  lead OTHER

Principal Investigators

• Robert W Alexander, MD · GARM USA

• Glenn C Terry, MD · Global Alliance for Regenerative Medicine (GARM)

• Ryan JP Welter, MD, PhD · Regeneris Medical

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-11

Primary Completion

2021-08-31

Completion

2022-12-31

Countries

• United States

Study Locations