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Trial record 13 of 33 for:    msc | Amyotrophic Lateral Sclerosis

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

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ClinicalTrials.gov Identifier: NCT04514952
Expanded Access Status : Available
First Posted : August 17, 2020
Last Update Posted : August 17, 2020
Sponsor:
Collaborator:
Hope Biosciences Stem Cell Research Foundation
Information provided by (Responsible Party):
Hope Biosciences

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 Drug: 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:
  • Drug: HB-adMSCs
    Hope Biosciences autologous adipose-derived mesenchymal stem cells

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Contacts
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Contact: Sherry Diers, RN 3462419135 sherry@hopebio.org
Contact: David Gonzalez, RN 3462419133 david@hopebio.org

Locations
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United States, Texas
River Oaks Hospital and Clinics Available
Houston, Texas, United States, 77027
Contact: Marianne England       mengland@adhealthcare.com   
Sponsors and Collaborators
Hope Biosciences
Hope Biosciences Stem Cell Research Foundation
Investigators
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Principal Investigator: Rajiv Thakur, MD River Oaks Hospital and Clinics
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Responsible Party: Hope Biosciences
ClinicalTrials.gov Identifier: NCT04514952    
Other Study ID Numbers: Amyotrophic Lateral Sclerosis
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020
Keywords provided by Hope Biosciences:
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