The primary purpose of this study is to assess the safety and optimal delivery of the Neo-Kidney Augment (NKA) when implanted at one site in a recipient kidney. NKA is made from expanded autologous, homologous, selected renal cells (SRC) obtained from the patient's kidney biopsy.
|Chronic Kidney Disease||Biological: Implantation of SRC||Phase 1|
Therapeutic intervention with NKA is intended to delay the need for renal replacement therapy (dialysis or transplant) which at this time, is inevitable in patients with CKD. NKA is composed of autologous, homologous selected renal cells (SRC) formulated in a Biomaterial (gelatin-based hydrogel). SRC are the biologically active component of NKA. Proof of principle for SRC as the biologically active component of NKA was established in multiple models of CKD. Based on nonclinical efficacy and safety data, a single NKA dose will be delivered to patients in this FIH clinical trial. This dose provides a minimum of a 1.5-fold safety margin over doses delivered safely in nonclinical studies. In addition, this dose demonstrated efficacy in a nonclinical disease model.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-Label Safety and Delivery Optimization Study of an Autologous Neo-Kidney Augment (NKA) in Patients With Chronic Kidney Disease (CKD)|
|Study Start Date :||April 2013|
|Primary Completion Date :||December 2014|
|Study Completion Date :||December 2014|
Case | HBS Case Collection | October 2009 (Revised August 2014)
Tengion: Bringing Regenerative Medicine to Life
Elie Ofek and Polly Ross Ribatt
Tengion is a young biotech company that is at the frontier of regenerative medicine—a nascent field that seeks to promote the creation of new cells and tissue to repair or replace tissue or organ function lost due to age, disease, damage, or congenital defects. In late 2008 Tengion management faces a difficult dilemma. In light of the financial crises, the company needs to manage cash burn by prioritizing its R&D efforts. CEO Nichtberger needs to recommend to the board which of two promising new medical treatments to keep developing while placing the other on hold. In comparing the two options, a host of factors need to be considered—these range from assessing the regulatory challenges, manufacturing challenges, marketing challenges (in particular pricing), and partnering challenges. Each of the treatments would target a unique patient population that differs in both size and composition. Tengion must also consider how quickly it might expect to bring each of the two treatments to market. The decision could have significant long-term implications for the company's ultimate survival and success.
Keywords: Decision Choices and Conditions; Financial Crisis; Entrepreneurship; Health Care and Treatment; Technological Innovation; Product Launch; Product Development; Research and Development; Biotechnology Industry; United States;