The SVF-2 uniquely harvests and isolates a patient’s own stromal and vascular cells, including stromal progenitor cells, to help control pain, reduce inflammation and repair inflamed tissues in the osteoarthritic knee. FDA Phase II clinical trials for this minimally invasive procedure have shown no serious adverse events and significant improvements in pain, stiffness and function (see results of the clinical study here: AJSM Phase IIb ).
Our modular tissue processing platform enables point-of-care therapy for a broad range of indications. By reducing an entire cell-processing facility to a single disposable device, physicians can extract and process adipose tissue in real time using proven scientific methods, controls and reagents. This platform provides scalable cell processing for hospitals, medical practices and other surgical or clinical settings.
Clinical trials considering the effectiveness of the SVF-2 in treating peripheral vascular disease in small & large vessels, diabetic ulcers, and volume augmentation have already been completed, with more coming soon. More information about these trials can be found here.
Our clinical pipeline features targeted therapeutic applications and clinical development in three primary therapeutic domains. More details on specific clinical trials can be found here.
The osteoarthritis trial is a multi-site pivotal clinical trial that is double-blinded, randomized, placebo-controlled, dose-escalated, and statistically powered. The trial has IDE and is compliant with FDA regulations.
Human data for Diabetic Ulcers – Pilot
Human data in development – Pilot
Human data in development – pilot
Human data in development – pilot
A study describing advancements that injectable carriers, tissue grafts, anisotropically oriented biomaterials and cell sheets have achieved in preclinical models as stem cell carriers for tendon repair.
https://pubmed.ncbi.nlm.nih.gov/26238455/
A study evaluating the safety of adipose-derived SVF for intra-articular injection of the knee and the feasibility of an intra-articular injection for pain relief in osteoarthritic knees.
https://stemcellres.biomedcentral.com/articles/10.1186/scrt426
A study evaluating the safety of intra-articular injection of SVF and feasibility for reduction of pain in osteoarthritic knees.
https://drdumanian.com/wp-content/uploads/2015/06/stem_cells_for_arthritis.pdf
A study examining the effects of adipose-derived, stem cell-conditioned medium on alopecia.
https://cms.galenos.com.tr/Uploads/Article_42644/jtad-14-107-En.pdf
A study examining the use of stromal and vascular cells for the treatment of diabetic foot ulcers (peripheral vascular disease).
https://pubmed.ncbi.nlm.nih.gov/24691309/
A study examining the effect and possible mechanism of adipose-derived, stem cell-conditioned medium on hypertrophic scars.
https://stemcellres.biomedcentral.com/articles/10.1186/s13287-016-0356-6
A summary and review of the proliferation and capacity of adipose-derived stem cells as a regenerative tool in plastic and reconstructive surgery
A clinical trial for safety and feasibility examining the use of stromal vascular cells for the treatment of erectile dysfunction.
https://pubmed.ncbi.nlm.nih.gov/29960873/
A clinical trial for safety and feasibility examining the use of stromal vascular cells for the treatment of COPD.