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Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease

Autologous Purified Bone-Marrow-Derived Stem Cell Therapy for Motor Neuron Disease

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03067857
Enrollment
40
Registered
2017-03-01
Start date
2016-09-30
Completion date
2019-08-31
Last updated
2018-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Primary Lateral Sclerosis, Progressive Bulbar Palsies, Progressive Muscular Atrophy

Brief summary

Herein, the investigators study the safety and efficacy of transplanting purified autologous bone marrow-derived stem cells transplanted via the intrathecal route by interventional radiology and the intravenous route.

Detailed description

A motor neuron disease (MND) is any of several neurological disorders that selectively affect motor neurons, the cells that control voluntary muscles of the body. They include amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), progressive muscular atrophy (PMA), progressive bulbar palsy (PBP) and pseudobulbar palsy; spinal muscular atrophies are also sometimes included in the group.They are neurodegenerative diseases that cause increasing disability and eventually, death. In spite of intensive research, motor neuron diseases (MNDs) are still incurable. Some of the key factors in this failure to find a cure have been the lack of human cell-based disease models for molecular analysis and drug screening and the difficulty of obtaining homogeneous populations of specific cell types for clinical applications. Stem cell biology has the potential to transform our understanding of disease processes and to revolutionize our approach to develop novel therapies for MNDs. In this study, the investigators suggest a protocol for the treatment of MND by transplantation of purified autologous bone marrow-derived stem cells via the intrathecal and intravenous route.

Interventions

BIOLOGICALStem Cells

Autologous bone marrow-derived stem cell populations injected via the intravenous and intrathecal routes.

Sponsors

Stem Cells Arabia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Patients age 24-20 years old * Patients with the diagnosis of definite Motor Neuron Disease

Exclusion criteria

* HIV/HBV/HCV * Malignancies * Bleeding * Pneumonia * Renal failure * liver dysfunction * Severe anemia (hb \< 8) * Bone Marrow diseases * Pregnancy and lactation * Acute medical conditions/infections such as respiratory infections * ventilatory support

Design outcomes

Primary

MeasureTime frame
Changes in Functional Rating Scale - via questionnaire6 months

Secondary

MeasureTime frame
Change in Appel Scale4 months
Change in SF-36 (The Short Form (36) Health Survey is a 36 Item)4 months
Change in Forced Vital Capacity (FVC)4 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026