CClinicalTrials.gg
Status unknownNCT03067857Updated Jun 6, 2018

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

A Phase 1/2 interventional study of Stem Cells in Motor Neuron Disease, Amyotrophic Lateral Sclerosis and Primary Lateral Sclerosis, sponsored by Stem Cells Arabia. Status unknown. Open to participants aged 24 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-06-06.

Sponsored by Stem Cells Arabia · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
24 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Motor Neuron Disease
  • Amyotrophic Lateral Sclerosis
  • Primary Lateral Sclerosis
  • Progressive Muscular Atrophy
  • Progressive Bulbar Palsies
03

In context

Motor Neuron Disease

717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.

This study's planned enrollment of 40 is above the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.

Browse Motor Neuron Disease studies →

Lead sponsor

Stem Cells Arabia is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Stem Cells

    Intravenous and Intrathecal thecal transplantation via interventional radiology of purified autologous bone-marrow derived specific stem cell populations.

    Biological: Stem Cells

Interventions

  • BiologicalStem Cells

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

06

What researchers measure

Primary outcomes

  1. Changes in Functional Rating Scale - via questionnaire

    Time frame: 6 months

Secondary outcomes

  1. Change in Appel Scale

    Time frame: 4 months

  2. Change in SF-36 (The Short Form (36) Health Survey is a 36 Item)

    Time frame: 4 months

  3. Change in Forced Vital Capacity (FVC)

    Time frame: 4 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03067857
Lead sponsor
Stem Cells Arabia
Responsible party
Sponsor
First posted
Mar 1, 2017
Start date
Sep 2016
Primary completion
Jan 2019 (estimated)
Completion
Aug 2019 (estimated)
Last update
Jun 6, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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