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

Status unconfirmed · Not applicable

Conditions studied: Osteoarthritis, Rheumatoid Nodule, Degenerative Joint Disease, Tendinopathy, Tendinosis, Back Pain

In brief

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.

Key facts

Study ID: NCT03090672
Run by: Robert W Alexander, MD
People needed: 300
Starts: 2017-03-11
Expected to finish: 2022-12-31
Last updated by the study team: 2020-01-18

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

Regeneris Medical — North Attleboro, Massachusetts, United States (enrolling)
Regeneris Medical — North Attleboro, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.