Expanded Access Protocol: Repeated Administration of Nurown® (Autologous MSC-NTF Cells) for the Treatment of ALS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04681118|
Expanded Access Status : Available
First Posted : December 23, 2020
Last Update Posted : December 23, 2020
|Condition or disease||Intervention/treatment|
|Amyotrophic Lateral Sclerosis||Biological: NurOwn (MSC-NTF cells)|
This is an Intermediate-size patient population Expanded Access Protocol (EAP) to provide NurOwn® (MSC-NTF cells) for eligible ALS participants who completed the BCT-002-US phase 3 ALS clinical trial and have received all three IT treatments.
The participants will undergo up to three intrathecal (IT) treatments with NurOwn® (MSC-NTF cells).
The first treatment will be at Visit 3, approximately 5-6 weeks after the BMA (Visit 2), with the subsequent treatments at Visit 4 and Visit 5.
Following the third and last treatment, the participant will be followed for three additional monthly visits (in-person, if feasible, or by telephone call or telemedicine in consideration of the ongoing COVID-19 pandemic) through week 28, during which the ALSFRS-R and safety assessments will be collected.
|Study Type :||Expanded Access|
|Expanded Access Type :||Intermediate-size Population, Treatment IND/Protocol|
|Official Title:||Intermediate-size Patient Population Expanded Access Protocol: Repeated Administration of Nurown® (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors) for the Treatment of Amyotrophic Lateral Sclerosis (ALS)|
- Biological: NurOwn (MSC-NTF cells)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04681118
|Contact: Mary Kay Turner||201-488-0460 ext email@example.com|
|Contact: Yael Gothelf, Ph.D.||646-666-3188 ext firstname.lastname@example.org|
|United States, California|
|University of California Irvine Alpha Stem Cell Clinic||Available|
|Irvine, California, United States, 92697|
|Principal Investigator: Namita A Goyal|
|Cedars-Sinai Medical Center||Available|
|Los Angeles, California, United States, 90048|
|Principal Investigator: Matthew H Burford, MD|
|California Pacific Medical Center||Available|
|San Francisco, California, United States, 94115|
|Principal Investigator: Jonathan Katz, MD|
|United States, Massachusetts|
|Massachusetts General Hospital||Available|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator: James D Berry, MD|
|UMass Medical School||Available|
|Worcester, Massachusetts, United States, 01655|
|Principal Investigator: Robert H Brown, D.Phil., M.D|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator: Anthony Windebank, MD|