Stem Center receives authorization to begin pivotal clinic trial of Renevia hidrogel

The Spanish Agency of Medicines and Medical Devices (AEMPS) authorized Stem Center to conduct a randomized, evaluator-blinded, delayed-treatment-controlled study of the effectiveness and safety of Renevia™ as a resorbable matrix for the delivery of autologous adipose-derived (ADSCs) cells, to treat facial lipoatrophy defects arising from HIV infection.

In this trial, Renevia™ biomaterial will be used together with autologous adipose cells derived from the patient's adipose tissue. This cells will be injected in the patient's face wherever there had been a lose of fat under the skin (subcutaneous lipoatrophy). Lipoatrophy is estimated to occur in 35-50% of the 10 million HIV patients on antiretroviral therapy.

Stem Center, a biotechnology company devoted to cellular surgery, will work in collaboration with BioTime, Inc, owner of Renevia, in the development of this clinical trial. The Principal Investigator will be Ramon Llull, MD, PhD, a leading expert on advanced regenerative therapies based on adipose tissue, and the research will take place in Stem Center's facilities, located within the Quiron Palmaplanas hospital.

Facial lipoatrophy

Facial lipoatrophy (facial wasting) is a frustrating reality for many HIV-positive patients. Although facial lipoatrophy does not endanger life, it is one of the most problematic and stigmatizing HIV complications. Several studies showed that this condition can have negative effects on patients' self esteem and quality of life; moreover, it can significantly contribute to depression development. It is thought that lipoatrophy is an adverse effect of antiretroviral therapy (ARV), and thus this can affect the "relationship" of patients with the drugs they are taking, resulting in a bad adherence or in the treatment discontinuation, despite keeping an undetectable viral load and a healthy immunological system.

Lipoatrophy is an abnormal loos of body fat, specifically of fat located immediately under the skin (subcutaneous fat). One of the most prominent traits of facial lipoatrophy is sunken cheeks (cheeks without volume that look like excavated). It is possible that people suffering from mild facial lipoatrophy are hardly aware of it, and the condition can go unnoticed by others. If lipoatrophy gets worse the facial musculature lines (facial muscles) can be seen through the skin.

Although lipoatrophy is thought to be an adverse effect of antiretroviral therapy, it is not yet clearly understood why or how it occurs in HIV-positive patients, therefore, the treatment development has been a challenge. Fortunately, the effective management of facial lipoatrophy has been a priority for several researchers and companies.

At present, commonly used products for the treatment of HIV-related lipoatrophy include dermal fillers or products that trigger fibrotic reactions which create fibrous tissue that has an effect of bulking the skin, but not a restoration of natural subcutaneous fat with its associated texture and appearance. A full course of treatment of those products can require multiple injections over a period of several months.

About the clinical trial with Renevia™

The study will include up to 92 HIV-positive patients between 18-65 years of age. Subjects will be randomized (50% possibility to be in each group) to receive an immediate treatment course of Renevia™ with cells or a delayed treatment. Throughout the 6 months of the study, the change in skin thickness in the areas previously presenting a defect will be assessed. The aesthetic improvement of the results and the changes in patients self esteem and life quality will also be measured up.

BioTime expects that a single treatment of Renevia™ with adipose-derived cells when injected with a small gauge cannula will result in a reconstitution of normal subcutaneous fat and restoration of skin contour.

HyStem® Technology and Renevia™

BioTime’s HyStem® hydrogels, including Renevia, are a family of unique and proprietary biomaterials that are designed to function as adhesion matrices for the stable attachment and survival of cells. The failure rate in many applications of cell grafts without such a matrix is high because of difficulties in achieving cell attachment and survival. The achievement of high success rates for cell grafts would create opportunities to develop cell therapies for many high unmet medical needs. A unique feature of the proprietary technology is that it allows the mixture of cells with the matrix in a liquid form such that the cells and matrix can be injected easily and safely through a small gauge syringe, and then the matrix can polymerize around the cells to create a three-dimensional tissue within the body. HyStem hydrogels are currently sold worldwide by BioTime and its distributors for pre-clinical research for a wide array of applications in regenerative medicine including the engraftment of cells in the brain, liver, cartilage and bone, heart, and vocal cords. Premvia,TM a HyStem based hydrogel, is a recently FDA-cleared medical device indicated for the management of wounds. BioTime’s HyStem technology is covered by two issued US patents with applications pending in the EU, Canada, Japan, and Australia.