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MSC_NTF cells transplantation by multiple intramuscular injections at 24 separate sites, in addition to a single intrathechal into the CSF

Phase 2

Amyotrophic Lateral Sclerosis | Monoclonal antibody | Neurology |Brainstorm Cell Therapeutics Inc.|Last Updated: Mar 8, 2018

Success Probability

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

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Clinical trial landscape

MSC_NTF cells transplantation by multiple intramuscular injections at 24 separate sites, in addition to a single intrathechal into the CSF · 1 trial · 1 indication

Phase 2 1
NCT01777646Autologous Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis
COMPLETED14 Analytics
PHASE2COMPLETED
Autologous Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety evaluation and tolerability of a single treatment administration in an escalating-dose of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF)
At baseline and up to 6 month following treatment administration

Secondary Endpoints

Changes in the progression rate of the disease as evidenced by changes in the ALS functional rating scale
At baseline and up to 6 month following treatment administration
Changes in muscle strength grading (MVIC) by muscle chart
At baseline and up to 6 month following treatment administration
Changes in muscle bulk estimated by MRI of the upper and lower extremities
At baseline and up to 6 month following treatment administration
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MSC-NTFEXPERIMENTAL -

Interventions

NameTypeDescription
MSC_NTF cells transplantation by multiple intramuscular injections at 24 separate sites, in addition to a single intrathechal injection into the CSFBIOLOGICAL -
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Eligibility Criteria

Age Range20 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patient must fulfill El Escorial criteria (APPENDIX 2) for definite or probable ALS (sporadic and not familial) 2. Participants, either men or non pregnant women are between 20 and 75 years of age. 3. The patient is mentally intact and psychologically stable 4. Patients will ...

Countries:Israel
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Frequently asked questions about MSC_NTF cells transplantation by multiple intramuscular injections at 24 separate sites, in addition to a single intrathechal into the CSF

What is MSC_NTF cells transplantation by multiple intramuscular injections at 24 separate sites, in addition to a single intrathechal into the CSF?

It is an investigational cell therapy being studied for amyotrophic lateral sclerosis (ALS). The treatment involves autologous mesenchymal bone marrow stromal cells that secrete neurotrophic factors, given through multiple intramuscular injections at 24 separate sites plus a single intrathecal injection into the cerebrospinal fluid.

What is MSC_NTF cells transplantation used for in ALS?

It is being studied as a treatment for amyotrophic lateral sclerosis, a progressive neurological disease. The approach uses a patient's own bone marrow-derived mesenchymal stromal cells that secrete neurotrophic factors, delivered by intramuscular injections at 24 sites and one intrathecal injection into the cerebrospinal fluid.

Who is developing MSC_NTF cells transplantation for ALS?

Brainstorm Cell Therapeutics Inc., which trades under the ticker BCLI, is the developer of this autologous MSC-NTF cell therapy for amyotrophic lateral sclerosis. The company sponsored the Phase 2 study of the treatment.

What phase is MSC_NTF cells transplantation in for ALS?

It is in Phase 2 development. The single completed trial, NCT01777646, was a Phase 2 study that enrolled 14 patients with amyotrophic lateral sclerosis in Israel. It was an uncontrolled, non-randomized, open-label study, and no active trials are currently listed.

What clinical trial has studied MSC_NTF cells transplantation for ALS?

The trial is NCT01777646, titled Autologous Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in Patients With Amyotrophic Lateral Sclerosis (ALS). It was a completed Phase 2 study that enrolled 14 participants aged 20 years and older in Israel, with no healthy volunteers included.

Is MSC_NTF cells transplantation the same as MSC-NTF?

Yes. MSC_NTF cells transplantation by multiple intramuscular injections at 24 separate sites, in addition to a single intrathechal into the CSF is also written as MSC_NTF cells transplantation by multiple intramuscular injections at 24 separate sites, in addition to a single intrathechal injection into the CSF. Both refer to the same autologous MSC-NTF cell therapy developed by Brainstorm Cell Therapeutics for ALS.