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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Robert W Alexander, MD; Ryan Welter, MD, PhD
• Collaborators: Global Alliance for Regenerative Medicine; Regeneris Medical

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