Recruiting

Regenerative Therapy

Sponsor:

Robert W Alexander, MD

Code:

NCT03090672

Conditions

Osteoarthritis

Rheumatoid Nodule

Degenerative Joint Disease

Tendinopathy

Tendinosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Normal Saline

Tissue Stromal Vascular Fraction

Platelet Rich Plasma

Cellular Stromal Vascular Fraction

Study Details

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

Study ID

NCT03090672

Start date

Mar 11, 2017

Status verified date

Jan, 2020

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Aug 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: tSVF + PRP Arm1

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

experimental: tSVF + PRP + cSVF Enrichment Arm 2

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

experimental: Normal Saline IV + cSVF Arm 3

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

Interventions

Normal Saline

Normal Saline IV delivery

Tissue Stromal Vascular Fraction

tSVF

Platelet Rich Plasma

PRP

Cellular Stromal Vascular Fraction

cSVF

Primary outcome measure

  • Participants with complications [ Time Frame: 1 month ]

Central Contacts and Locations

Locations

Regeneris Medical

Recruiting

North Attleboro, Massachusetts, United States, 02760

Contacts

Regeneris Medical

Recruiting

North Attleboro, Massachusetts, United States, 02760

Contacts

Principal Investigator:

Glenn C Terry, MD

More Information

Sponsor

Robert W Alexander, MD

Last update posted

Jan 18, 2020

Last verified

Jan, 2020

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Robert W Alexander, MD on 2020-01-18.