Expanded Access Protocol: Repeated Administration of Nurown® (Autologous MSC-NTF Cells) for the Treatment of ALS
a study on Amyotropic Lateral Sclerosis (ALS)
Summary
- Eligibility
- for people ages 18-63 (full criteria)
- Location
- at Irvine, California and other locations
- Dates
- study started
Description
Summary
Expanded Access for treatment with investigational product MSC-NTF cells(NurOwn®) for participants who completed all scheduled treatments and follow-up assessments in BCT-002-US study
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)
Details
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.
Keywords
Amyotrophic Lateral Sclerosis Motor Neuron Disease Sclerosis NurOwn (MSC-NTF cells)
Eligibility
You can join if…
Open to people ages 18-63
- Participation in the BCT-002-US study, successful completion of all scheduled treatments and follow-up assessments.
2 Able to provide to the Investigator written informed consent regarding the investigational drug, or, as applicable, on whose behalf a legally authorized representative of the participant has provided such consent.
- Able to safely undergo a bone marrow aspiration.
You CAN'T join if...
- Inability to lie flat for the duration of intrathecal cell transplantation and/or bone marrow biopsy, or inability to tolerate treatment procedures for any other reason (lying flat with BiPAP or NIV are not exclusionary).
- History of clinically significant autoimmune disease (excluding thyroid disease) myelodysplastic or myeloproliferative disorder, leukemia or lymphoma, whole body irradiation, hip fracture, or severe scoliosis.
- Any unstable clinically significant medical condition other than ALS (e.g., within six months of baseline, had myocardial infarction, angina pectoris, and/or congestive heart failure), treatment with anticoagulants that, in the opinion of the Investigator, would compromise the safety of the participant.
- Any history of malignancy within the previous 5 years, with the exception of non-melanoma localized skin cancers (with no evidence of metastasis, significant invasion, or re-occurrence within three years of baseline).
- Current use of immunosuppressant medication or use of such medication within 4 weeks of the pre-treatment visit.
- Any history of acquired or inherited immune deficiency syndrome.
- Tracheostomy and/or mechanical ventilation. Feeding tube use, BiPAP or NIV are not exclusionary.
- Pregnant women or women currently breastfeeding or unwilling to use effective birth control methods during the treatment (if of childbearing age).
- Positive test result for Hepatitis B virus (HBV; surface antigen (HBsAg) and IgM antibodies to core antigen (IgM anti-HBc)), Hepatitis C virus (HCV), Human Immune deficiency virus (HIV) 1 and 2.
Locations
- University of California Irvine Alpha Stem Cell Clinic
not accepting new patients
Irvine California 92697 United States - Cedars-Sinai Medical Center
not accepting new patients
Los Angeles California 90048 United States
Details
- Status
- not accepting new patients
- Start Date
- Sponsor
- Brainstorm-Cell Therapeutics
- ID
- NCT04681118
- Study Type
- Expanded Access
- Last Updated
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