Clinical Trials
7
Trial Phases
3 Phases
Drug Approvals
0
Drug Approvals
No drug approvals found
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Clinical Trials
Distribution across different clinical trial phases (6 trials with phase data)• Click on a phase to view related trials
Efficacy and Safety of MSC-NTF (NurOwn) in Participants With Early Symptomatic ALS and Moderate Disease Presentation in ALS (ENDURANCE STUDY)
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis
- Interventions
- Biological: Debamestrocel - MSC-NTF (NurOwn)Biological: Placebo
- First Posted Date
- 2025-05-15
- Last Posted Date
- 2025-05-22
- Lead Sponsor
- Brainstorm-Cell Therapeutics
- Target Recruit Count
- 200
- Registration Number
- NCT06973629
- Locations
- 🇺🇸
Barrow Neurological Institute, Phoenix, Arizona, United States
🇺🇸University of California San Diego Medical Center, La Jolla, California, United States
🇺🇸University of Southern California, Los Angeles, California, United States
Expanded Access Protocol: Repeated Administration of Nurown® (Autologous MSC-NTF Cells) for the Treatment of ALS
- Conditions
- Amyotrophic Lateral Sclerosis
- First Posted Date
- 2020-12-23
- Last Posted Date
- 2024-04-23
- Lead Sponsor
- Brainstorm-Cell Therapeutics
- Registration Number
- NCT04681118
- Locations
- 🇺🇸
University of California Irvine Alpha Stem Cell Clinic, Irvine, California, United States
🇺🇸California Pacific Medical Center, San Francisco, California, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
Safety and Efficacy of Repeated Administration of NurOwn (MSC-NTF Cells) in Participants With Progressive MS
- Conditions
- Multiple Sclerosis, Chronic Progressive
- First Posted Date
- 2019-01-10
- Last Posted Date
- 2023-12-04
- Lead Sponsor
- Brainstorm-Cell Therapeutics
- Target Recruit Count
- 23
- Registration Number
- NCT03799718
- Locations
- 🇺🇸
University of Southern California, Los Angeles, California, United States
🇺🇸Stanford University School of Medicine, Redwood City, California, United States
🇺🇸The Mount Sinai Hospital, New York, New York, United States
Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- First Posted Date
- 2017-09-12
- Last Posted Date
- 2024-02-29
- Lead Sponsor
- Brainstorm-Cell Therapeutics
- Target Recruit Count
- 196
- Registration Number
- NCT03280056
- Locations
- 🇺🇸
University of California Irvine Alpha Stem Cell Clinic, Irvine, California, United States
🇺🇸Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸California Pacific Medical Center, San Francisco, California, United States
Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study of Autologous MSC-NTF Cells in Patients With ALS
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- First Posted Date
- 2013-12-23
- Last Posted Date
- 2024-06-06
- Lead Sponsor
- Brainstorm-Cell Therapeutics
- Target Recruit Count
- 48
- Registration Number
- NCT02017912
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸UMass Medical School, Worcester, Massachusetts, United States
🇺🇸Mayo Clinic, Rochester, Minnesota, United States
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News
ALS Community Files Citizens' Petition Seeking FDA Approval for NurOwn Stem Cell Therapy
A coalition of ALS patients and families has filed a 309-page Citizens' Petition with the FDA requesting approval of NurOwn, a neurotrophically-enhanced stem cell therapy developed by BrainStorm Cell Therapeutics.
FDA Clears Brainstorm Cell Therapeutics' Phase 3b Trial of NurOwn for ALS Treatment
Brainstorm Cell Therapeutics has received FDA clearance to initiate a Phase 3b trial of NurOwn for the treatment of Amyotrophic Lateral Sclerosis (ALS), marking a significant advancement in their clinical development program.
BrainStorm Advances NurOwn ALS Therapy with FDA-Aligned Phase 3b Trial Submission
BrainStorm Cell Therapeutics has submitted an IND amendment to the FDA for NurOwn, its autologous mesenchymal stem cell therapy for ALS, setting the stage for a pivotal Phase 3b clinical trial.
FDA Clears BlackfinBio's Gene Therapy Trial for Rare Hereditary Spastic Paraplegia
The US FDA has approved BlackfinBio's investigational new drug application for BFB-101, an adeno-associated virus gene therapy targeting hereditary spastic paraplegia type 47 (SPG47).
Global Neuroregeneration Therapy Market Set to Reach $64.8 Billion by 2034, Driven by AI and Stem Cell Innovations
The neuroregeneration therapy market is projected to grow at a 5.3% CAGR from 2024 to 2034, with North America leading the expansion due to advanced healthcare infrastructure and strong research funding.
Gene and Cell Therapies Show Promise in Treating CNS Disorders
The market for gene and cell therapies targeting CNS disorders was valued at approximately USD 1 billion in 2021 and is projected to grow significantly by 2034.
BrainStorm's NurOwn Shows Positive Survival Data in ALS Expanded Access Program
BrainStorm Cell Therapeutics presented data from its NurOwn Expanded Access Program (EAP) at the 2024 NEALS meeting, showing potential long-term survival benefits for ALS patients.
BrainStorm Cell Therapeutics Announces Update on Phase 3b NurOwn Trial for ALS
BrainStorm Cell Therapeutics will provide an update on its Phase 3b clinical trial for NurOwn, an investigational cell therapy for amyotrophic lateral sclerosis (ALS).
ALS Clinical Trial Landscape: Investigational Therapies Targeting Sporadic ALS
• Several clinical trials are underway for sporadic ALS, targeting TDP-43 pathology, STMN2 expression, and neuroinflammation. • Biogen's BIIB-105, AbbVie/Calico's ABBV-CLS-7262, Denali's DNL-343, and QurAlis' QRL-201 are among the therapies currently being evaluated in clinical trials. • Prilenia's Pridopidine and Clene's CNM-Au8 have completed Phase 2 trials, showing some positive trends in motor function and survival benefits, respectively. • The FDA is set to make a decision on Brainstorm Cell's NurOwn, a mesenchymal stem cell therapy, with an advisory committee meeting scheduled for September 27th.