What is Renevia®?
Renevia® is a medical device that was developed as a replacement for whole adipose tissue in cell assisted lipotransfer (CAL) procedures by recreating many aspects of the adipose tissue extracellular matrix. Renevia’s hydrogel polymer network provides the requisite amino acid sequences for adipose stromal vascular cell attachment and supports proliferation, localization, and adipogenic differentiation. Once implanted, Renevia® provides a 3-dimensional matrix with pliability comparable to that of native adipose tissue, restoring texture in the short term while promoting soft tissue regeneration in the long term.
An important attribute of the Renevia® hydrogel is its high water content > 98%. As a result, the hydrogel is highly permeable to oxygen, nutrients and other water-soluble metabolites. Renevia® mimics the extracellular matrix (ECM) and the individual components of the hydrogel can be cross-linked in situ, thereby allowing the seeding of cells prior to injection in vivo without compromising either the cells or the recipient tissues.
During the early development of Renevia®, alternatives to the Renevia hydrogel as a cell delivery vehicle were considered. With the long history of safe and effective use of injectable HA based dermal fillers, these materials were obvious candidates. Upon careful consideration however, existing dermal fillers as currently formulated do not possess the necessary properties to function effectively as cell delivery matrices. As these materials are already gelled or cross-linked, there is no practical way to obtain a uniform cell suspension. Even if achievable, the shear forces created when expressing such a viscous gel-cell mixture through a cannula would adversely affect in vivo cell viability. The ability to mix cells with Renevia® during the pre-gel phase, deliver the cell/hydrogel mixture through a cannula, and have the subsequent gelation occur in situ without compromising the cells or the recipient tissue is a key element of the design criteria. In addition, currently available dermal fillers do not contain the requisite physical and chemical structure for cell attachment and proliferation. For these reasons, the currently marketed dermal fillers cannot be considered viable alternatives to Renevia® as a cell delivery matrix.
Renevia® is part of the HyStem® hydrogel family of proprietary injectable matrices, which are designed to facilitate the survival and growth of transplanted cells. To learn more about the HyStem hydrogel technology and composition of Renevia®, click here.
Renevia Pivotal Clinical Trial
BioTime, Inc. is currently sponsoring the following pivotal trial:
A Randomized, Evaluator-Blinded, Delayed-Treatment-Controlled Study of the Effectiveness and Safety of Renevia®, A Resorbable Matrix For The Delivery Of Autologous Adipose Derived Cells To Treat Subcutaneous Facial Lipoatrophy Defects Arising From HIV.”
This clinical trial has not been submitted to the US FDA for review and there are no clinical trial sites in the USA. Renevia® is not cleared for marketing in the United States.
There is no cost for participants to take part in this study. If you are interested in participating, please call: +(34) 971 910 074 for more information.
What is the Purpose of the Study?
Renevia® has been tested in healthy volunteers (Renevia-01 Safety Trial) and was well-tolerated with no significant adverse effects. The Renevia-02 Clinical Study is designed to demonstrate the safety and efficacy of Renevia® for treating facial lipoatrophy (abnormal fat loss in the face) in HIV patients. Renevia® will be used to deliver the subject’s own fat-derived cells harvested via liposuction and implanted under the skin (subcutaneously) into areas of the patient’s face where there has been a loss of fat (lipoatrophy). The study will randomize patients into two groups, treated and delayed treatment group (untreated control). The primary efficacy will be determined by measuring the increase in skin thickness by 3-D imaging at 6 months post-treatment. Participants in the delayed treatment group will be offered treatment after an evaluation at 6 months.
To learn more about HIV-associated lipoatrophy and current treatment options, click here.
Currently there are two clinical sites in Spain:
- Stem Europe, Center Clinica USP Palma Planas, Palma de Mallorca, Baleares 07010
- Principal Investigator: Ramon Llull, MD, PhD.
- Clinica Tres Torres, Antiaging Group C/ Dr Carulla 12, Barcelona 08017
- Principal Investigator: Jesus Benito Ruiz, MD
Who Can Participate
- Male or female HIV+ patients between the ages of 18 – 65 years with mild to severe facial lipoatrophy.
- CD4+ count > 250 cells/mm3 and viral load < 5000 copies/cc.
- Has been receiving anti-retroviral treatment for at least 3 years.
- Desire to correct HIV-related volume deficit in the mid-face.
- Fat volume suitable for obtaining cells.
- No contraindication for anesthesia, pregnancy, lactation and coagulation disorders.
- Must be willing and able, in the Investigator’s opinion, to comply with all study requirements.
- The Study Coordinator will review the subject’s medical history and all the study requirements prior to the subject’s consenting to participate in the study.
Participation is strictly voluntary and patients may choose to leave the study at any time.
An overview of potential benefits and risks related to participation in this study is found here.
For any questions about eligibility for the Renevia-02 Clinical Trial, please contact:
Clinical Trials Coordinator, Stem Europe Tel: +(34) 639 70 72 00
e therapies based on lipotransfer.