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Individual Patient Expanded Access IND of Autologous HBadMSCs for the Treatment of Amyotrophic Lateral Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04514952
Expanded Access Status : No longer available
First Posted : August 17, 2020
Last Update Posted : July 7, 2021
Sponsor:
Collaborator:
Hope Biosciences
Information provided by (Responsible Party):
Hope Biosciences ( Hope Biosciences Stem Cell Research Foundation )

Brief Summary:
The drug for this submission is Hope Biosciences' autologous, adipose-derived culture-expanded mesenchymal stem cells (HB-adMSCs) for the treatment of a single patient with Amyotrophic Lateral Sclerosis (ALS). Stem cells have become a promising tool for the treatment of inflammatory and neurodegenerative conditions, including autoimmune diseases, traumatic brain injury, Parkinson's disease, and Alzheimer's disease.

Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Biological: HB-adMSCs

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: Individual Patient Expanded Access IND of Autologous HBadMSCs for the Treatment of Amyotrophic Lateral Sclerosis



Intervention Details:
  • Biological: HB-adMSCs
    Hope Biosciences autologous adipose-derived mesenchymal stem cells

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. Documented diagnosis of Amyotrophic Lateral Sclerosis.
  2. Capable of giving informed consent (signed, verbal or assent as applicable and as listed in the protocol)

Exclusion Criteria:

  1. Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSCs administration.
  2. Any abnormal, inexplicable laboratory result that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSCs administration.
  3. Participation in other interventional research studies within the past 30 days.
  4. Unwillingness to return for follow-up visits.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04514952


Locations
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United States, Texas
River Oaks Hospital and Clinics
Houston, Texas, United States, 77027
Sponsors and Collaborators
Hope Biosciences Stem Cell Research Foundation
Hope Biosciences
Investigators
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Principal Investigator: Rajiv Thakur, MD River Oaks Hospital and Clinics
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Responsible Party: Hope Biosciences Stem Cell Research Foundation
ClinicalTrials.gov Identifier: NCT04514952    
Other Study ID Numbers: HBALS01
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: October 2020
Keywords provided by Hope Biosciences ( Hope Biosciences Stem Cell Research Foundation ):
neurodegenerative
MSCs
stem cells
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases