Research and Clinical Trials

New Jersey Regenerative Institute provides non-surgical treatment for various musculoskeletal conditions, and specializes in using the patients’ own body to heal. This consists of either growth factors from the patients’ peripheral blood as in a routine blood draw, or from the pericytes/mesenchymal cells from a fat or bone marrow harvest.

There are a variety of regenerative cellular procedures that have been performed to date, but the most prominent ones the NJRI performs are platelet-rich plasma injections (PRP), bone marrow aspirate concentrate injections (BMAC) and lipoaspirate injections (Lipogems). Sometimes, the clinic supplements these procedures with prolotherapy (dextrose) injections, medical-grade ozone injections, or sam Sport® device.

Many of these procedures are unfortunately not covered by insurance companies, the reason being that although they are approved to be safe, they are still considered experimental in the United States due to the lack of outcomes data. The purpose of this database is to gather subjective and objective data on all of New Jersey Regenerative Institute’s patients who underwent any regenerative procedure, and monitor their improvement over time. This includes eight different validated functional measurements pertaining to a variety of body parts, as well as pain scores. Outcome forms will be filled out by patients through an easy electronic form every three, six, twelve and twenty-four months. With this longitudinal data, it will assist in patient recommendations, treatment choice, and improve the recognition of regenerative medicine to the FDA and insurance companies to change the face of medicine as we know it.

New Jersey Regenerative Institute has IRB approval for their Regenerative Outcomes Database from the Institutional Review Board at the Institute for Regenerative and Cellular Medicine based in Santa Monica, California. Our physicians are now conducting IRB certified research studies and are looking for volunteers with specific orthopedic conditions. Study subjects will receive these various treatments at a significantly reduced rate. Check them out below to see if you qualify:

Quantification of Micro-Fragmented Adipose Tissue or Body Fat 

Kessler Foundation Study: Micro-fragmented adipose tissue (MFAT) or body fat is used to treat a variety of medical conditions including those that cause pain in muscles, tendons, and ligaments. The purpose of this research study is to analyze and compare the characteristics of different MFAT materials produced by four commercially available systems to see if all methods produce similar products or if one method is better over others.

Enroll Now →

Shockwave Therapy for Knee Arthritis 

Kessler Foundation Study: examines the effectiveness of a treatment called extracorporeal shockwave therapy on decreasing pain for people with knee osteoarthritis. The shockwave device emits high-frequency sound waves, which interact with different tissues in your body and can provide healing effects. It does not produce electrical shocks.

Enroll Now →

FDA-compliant Study for the Treatment of Knee Osteoarthritis using GID BIO’s Stromal Vascular Fraction Cellular Therapy 

NOW CLOSED

New Jersey Regenerative Institute has been selected by GID BIO as a site for its FDA-compliant pivotal/Phase III clinical trial.

FDA Approved Clinical Trial for Knee Osteoarthritis Study

NOW CLOSED. Outcome data has been published. We are pleased to announce that New Jersey Regenerative Institute has been selected for participation in a first of its kind investigational cell clinical trial for knee osteoarthritis. 

1. Personalized Stem Cells, Inc. Announces First Patients Treated in FDA Approved Clinical Trial for Treatment of Osteoarthritis
2. Clinical Evaluation of Safety and Efficacy of a Central Current Good Manufacturing Practices Laboratory Produced Autologous Adipose-Derived Stromal Vascular Fraction Cell Therapy Product for the Treatment of Knee Osteoarthritis Published Study

Leg Pain/Herniated Disc Related to Sciatica Study

NOW CLOSED

New Jersey Regenerative Institute is conducting a clinical research study to examine the effectiveness of an investigational drug injection in reducing leg pain when compared with a control injection (an injection with no medication). 

Investigational New Treatment Alternative for Rotator Cuff Injury

NOW CLOSED

InGeneron Inc. is running a groundbreaking study on the New Jersey area and is looking to enroll patients with Rotator Cuff injuries. For more information about InGeneron Inc or the science behind Adipose-Derived Cells click the link below.

Military Affected by Meniscal Tears Study

Knee injuries are common among active-duty military personnel. One of the most common knee injuries is a meniscus tear, which can have several consequences. Immediately, the soldier may be separated from the military for over one year or assigned a permanent activity limiting duty profile. Over time, meniscal tears may also increase the risk of other knee injuries, such as osteoarthritis, which is one of the most common medical reasons for discharge from active duty service. The current standard of care includes conservative treatments, such as physical therapy and rest. Once conservative treatments fail, surgery is generally the next option. However, there is limited evidence that surgery is effective and some studies suggest it can accelerate the development of osteoarthritis. The goal of this study is to evaluate the efficacy of a regenerative treatment for meniscal tears termed micro-fragmented adipose tissue in reducing pain and restoring activity levels. We are recruiting active-duty military personnel and civilians (ANYONE UNDER 45 YEARS OLD) with meniscal tears and provide them with either the adipose tissue treatment or a control treatment consisting of saline. We will then follow these individuals for up to one year and evaluate differences in pain and function between the two groups. The ultimate goal is to show that micro-fragmented adipose tissue is a viable alternative for the treatment of meniscal tears in active-duty military personnel.

View this Clinical Trial’s Form →

1. With funding from The Geneva Foundation, Kessler Foundation and NJRI conduct an in-depth study of the role of hemarthroses in the development of osteoarthritis of the knee in military personnel
2. IOF President Receives $590,000 Award to Treat Meniscal Injuries in Military Personnel
3. Kessler Foundation Impact Report for the Military

Kessler Foundation receives award from Geneva Foundation for Cervigard FHP Neck Collar Study in Active Duty Personnel

Kessler Foundation received a $223,000 award from The Geneva Foundation for a two-year study investigating the safety and efficacy of the Cervigard Forward Head Posture (FHP) Neck Collar in active duty personnel. This funding builds upon the Foundation’s participation as one of the civilian sites involved with the Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) program, headquartered at the Uniformed Services University (USU) in Bethesda, Maryland. READ MORE

Micro-Fragmented Adipose Tissue for Shoulder Injuries in people with Spinal Cord Injuries Study

Drs. Gerard Malanga and Jay Bowen of New Jersey Regenerative Institute are collaborating with Kessler Institute for Rehabilitation, a leading inpatient and outpatient therapy center based in West Orange, NJ. In doing so, the doctors are making non-surgical regenerative treatments, such as PRP (Platelet Rich Plasma), Lipogems® (adipose/fat tissue), BMAC and Oxygen Ozone Therapy, available to disabled patients who are unable to undergo surgery due to spinal cord injuries, neurological/cardiac conditions and strokes. On August 25, 2017, Drs. Malanga and Bowen performed their first regenerative procedure on a patient with a spinal cord injury who was suffering from a torn rotator cuff. Due to the patient being wheelchair dependent and not able to undergo surgery because of health risks, Lipogems was performed which entailed a local anesthetic and the use of autologous (the patient’s own body) adipose tissue with an FDA-approved device specifically for breaking down fat cells for re-injection. Since there is no anesthesia involved and the fat tissue is taken directly from the patient’s body, the procedure is extremely low risk with no chance of the patient’s body rejecting it. New Jersey Regenerative Institute’s physicians and staff are proud to be working with Kessler Institute and the disabled populations who are in need of regenerative treatments to regain basic functionality and improve their quality of life.

If you would like more information or are interested in this research study, please contact us or contact the Kessler Institute for Rehabilitation at (973) 731-3600. Join us to improve your health and others. We thank you in advance for your participation.

Breaking News: Derfner Foundation funds novel research in regenerative medicine at Kessler Foundation to support a study of a new intervention for shoulder pain in wheelchair users under the leadership of Drs. Dyson-Hudson and Gerard Malanga.

1. Kessler Foundation Impact Report for Shoulder Injuries
2. Clinical evaluation of micro-fragmented adipose tissue as a treatment option for patients with meniscus tears with osteoarthritis: a prospective pilot study
3. Exercise and PRP Promising for Shoulder Pain in Wheelchair Users with Spinal Cord Injury
4. Chemical Profile and Clinical Efficacy of Adipose-Derived Mesenchymal Stromal Cell Therapy in the treatment of Knee Osteoarthritis
5. Autologous, micro-fragmented adipose tissue as a treatment for chronic shoulder pain in a wheelchair using individual with spinal cord injury: a case report 
6. Dyson-Hudson receives grant to study treatment for shoulder injuries in wheelchair users

Research Articles

1. Corticosteroids: Review of the History, the Effectiveness, and Adverse Effects in the Treatment of Joint Pain
2. Optimizing Platelet-Rich Plasma (PRP) Injections: A Narrative Review Optimizing PRP
3. Decrease in opioid and intra-articular corticosteroid burden after intra-articular hyaluronic acid for knee osteoarthritis treatment
4. Colorado biotech firm’s new cell therapy could eliminate the need for knee replacements
5. Adipose/Fat Therapy Evidence/Infographic
6. A New Paradigm for the Management of Knee Osteoarthritis: The Role of Hyaluronic Acid, Platelet-Rich Plasma (PRP) and Ozone in the Modulation of Inflammation: A Review
7. LIPOGEMS Announces Milestone of 35,000 Procedures
8. Football Players Health Study Tech Innovation Receives Funding
9. Public Safety Notification on Exosome Products
10. Bone Marrow Concentrate (BMC) Therapy in Musculoskeletal Disorders: Evidence-Based Policy Position Statement of American Society of Interventional Pain Physicians (ASIPP)