Anthony J. Windebank, M.D.

Closed for Enrollment

• A Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial Rochester, Minn.

  The primary objective of the study is to assess the safety of a novel biomaterial nerve scaffold, polycaprolactone fumarate (PCLF) conduit.

• A Dose-escalation Safety Trial for Intrathecal Autologous Mesenchymal Stem Cell Therapy in Amyotrophic Lateral Sclerosis Rochester, Minn.

  The purpose of this study is to determine determine the safety of intraspinal delivery of mesenchymal stem cells (MSCs) to the cerebral spinal fluid of patients with Amyotrophic Lateral Sclerosis (ALS) using a dose-escalation study.

• A Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate Safety and Efficacy of Transplantation of Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (MSC-NTF) in Patients with ALS (NurOwn) Rochester, Minn.

  This is a multi-center, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of autologous (self) transplantation of Neurotrophic factors-secreting Mesenchymal Stromal Cells (MSC-NTF, NurOwn™) in patients with ALS .

  MSC-NTF cells are a novel cell-therapeutic approach which is expected to effectively deliver Neurotrophic factors, which are potent survival factors for neurons, directly to the site of damage.

• A Phase 3, Randomized Double-Blind, Placebo-Controlled Multicenter Study to Evaluate Efficacy and Safety of Repeated Administration of NurOwn® (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors) in Participants With ALS Rochester, Minn.

  This study will evaluate the safety and efficacy of repeated administration of NurOwn® (MSC-NTF cells) therapy, which is based on transplantation of autologous bone marrow derived mesenchymal stromal cells (MSC), which are enriched from the patient's own bone marrow, propagated ex vivo and induced to secrete Neurotrophic factors (NTFs). The autologous NurOwn® (MSC-NTF cells) are back-transplanted into the patient intrathecally by standard lumbar puncture where neurons and glial cells are expected to take up the neurotrophic factors secreted by the transplanted cells

• A Single Patient Treatment Protocol for Autologous Mesenchymal Stem Cell Intraspinal Therapy in Amyotrophic Lateral Sclerosis (ALS) Rochester, Minn.

  The purpose of this study is to determine the safety of injecting mesenchymal stem cells through intraspinal delivery for the treatment of one patient who has amyotrophic lateral sclerosis (ALS).

• Intermediate-size Patient Population Expanded Access Protocol BCT-003-US: Repeated Administration of NurOwn® (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors) for the Treatment of Amyotrophic Lateral Sclerosis (ALS) (BCT-003 EAP) Rochester, Minn.

  The purpose of this study is to provide up to three intrathecal injections of NurOwn® (MSC-NTF cells, autologous Mesenchymal Stem Cells [MSC] Secreting Neurotrophic Factors [NTF]) given two months apart to patients who have completed all scheduled treatments and follow-up assessments in the BCT-002-US clinical trial. A bone marrow aspiration will be required as part of this program. It will take about 30 weeks for participants to complete the program.