Preclinical and early clinical case reports conducted in the EU indicate that adipose-derived regenerative cells (ADRC) extracted and isolated using InGeneron’s Transpose® RT System may be useful in a variety of therapeutic areas, such as Orthopedics, Wound Healing, as well as Aesthetics and Reconstruction.
Damage to the rotator cuff represents a vast majority of orthopedic shoulder injuries, often resulting in shoulder pain and occupational disability. This condition occurs frequently among middle-aged patients with high levels of athletic activity but is also a problem among elderly people. Risk factors besides age include smoking, diabetes mellitus, hypercholesterolemia, genetic predisposition, and involvement in activities that utilize frequent overhead movement of arms and shoulders.
Treatment options available to patients include non-surgical and surgical interventions. Surgical treatment allows primary repair within an open or arthroscopic procedure. Primarily, this treatment is conducted to relieve pain, increase the functional ability, and to achieve tendon-to-bone-healing. However, a recent meta-analysis
reports that the further development of these operative techniques does not result in better tissue healing or an improvement of the clinical results.21
ADRC use have previously been reported in orthopedic research settings, particularly to promote tendon-to-bone-healing. This is supported by findings that ADRC promote healing and capacity of regeneration after a suture of the subscapularis tendon in animal models.22 In collaboration with Sanford Health, one of the largest integrated healthcare providers in the US, InGeneron is currently conducting clinical trials to investigate the safety of the use of ADRC to treat rotator cuff tendinopathy compared to current standards of care.
Novel therapies in wound healing are centered around the use of adult stem cells, particularly mesenchymal stem cells (MSCs), which are crucial for physiologic tissue renewal and regeneration after injury.27, 28 With a prevalence of 1% to 2% among the western population, ulcerations of the lower leg represent the largest group of chronic wound healing disorders.3, 4 In many cases these ulcerations do not respond to currently available therapies and cause significant pain and morbidity.3, 4
Many of these chronic wounds display limited capacity for healing and a high degree of inflammation.2 Local administration of adipose-derived regenerative cells (ADRC) has demonstrated the potential to jumpstart the healing process and reduce pain.5
InGeneron is currently conducting clinical trials in the US, under FDA IDE approval, to investigate the treatment safety and potential efficacy of treatment of chronic venous stasis leg ulcers with ADRC.
Aesthetics and Reconstruction
Fat grafting or lipofilling in aesthetics and reconstruction is a widespread surgical procedure. Clinical indications for these therapies have been constantly expanding over the last two decades. The use of autologous fat grafting has been shown to have beneficial effects on tissues, and in some cases to provide
durable correction of physical and surgical deformities.6 Aesthetic and reconstruction indications in which lipofilling, regenerative cells or a combination of both are used include breast augmentation, breast reconstruction, wrinkle treatment, scar treatment, alopecia treatment, and atrophic rhinitis treatment.
Advantages of the InGeneron SmartGraftTM System
Specifically, the SmartGraftTM System is a convenient and pre-sterilized method of removing excess fluids including lipids. It comes in two convenient sizes depending on the volume of fat to be processed and utilized, and it allows for maintenance of a closed system during concentration and removal of liquid. The
SmartGraftTM System provides the physician with a convenient, sterile and rapid concentration of cells with the capability to remove excess fluid removal from fat grafts, all within the same Processing Unit as is used to obtain the regenerative cells for addition to the graft.