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Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT04064983
Expanded Access Status : No longer available
First Posted : August 22, 2019
Last Update Posted : July 6, 2021
Sponsor:
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-adMSC's) for the treatment of a single patient with Parkinson's Disease (PD). PD is an aggressive neurodegenerative disease that attacks neurons, specifically dopaminergic neurons, in regions of the brain associated with movement. Accumulation of alpha-synuclein develop Lewy bodies, which aggregate in the brain. Patient's experience tremor, bradykinesia, rigid muscles, impaired posture and balance, and changes in speech and writing ability. Other physiological symptoms include cognitive decline, depression, difficulty chewing and swallowing, sleep disorders, bladder and bowel issues, changes in blood pressure and olfaction, as well as significant pain and fatigue. There is no cure for PD.

Condition or disease Intervention/treatment
Parkinson Disease Biological: HB-adMSCs

Detailed Description:

Once the eligibility is confirmed, approximately 1-3 after the screening/baseline visit, the subject will return for the first infusions. Subsequent treatments will occur 2 weeks apart for two infusions and then monthly for 6 additional infusions. Total number of infusions will be eight.

On each of these visits, the subject will receive one autologous HB-adMSC infusion of 200 million (2 x 10^8 cells) total cells suspended in 250 mL normal saline for IV infusion. Every infusion visit will include the following procedures:

  1. Interval H&P and concomitant medications update,
  2. Unified Parkinson's Disease Rating Scale exam (UPDRS),
  3. Hoehn and Yahr score
  4. Schwab and England Activities of Daily Living Scale
  5. Subject will complete a quality of life survey "Social Roles and Activities"
  6. A video documenting subject walking, standing from sitting, writing a paragraph of 3 lines and drawing a spiral will be recorded at each visit beginning with the first infusion visit.
  7. Vital signs monitoring will be initiated (Heart Rate, BP, Resp., Temp., SpO2),
  8. A peripheral IV line will be inserted,
  9. *A blood and urine sample for clinical labs (CBC with Platelets, CMP, PT, PTT, complete Urinalysis as well as baseline TNF-a, IL6 and CRP)

11. A "time out" verification of patient/consent/procedure/cell product will be performed, 12. The HB-adMSC infusion will be given by through the peripheral IV, infused over 1 hour at a rate of 250ml/hr (83gtts/minute) 13. Assessment for Infusion Related AE/SAEs

Follow-up Visits Week 4, 32, 36, 40, 44, 48, and 52

The subject will undergo the following procedures at each follow-up visit without infusion:

  1. Interval H&P and concomitant medications update,
  2. Unified Parkinson's Disease Rating Scale exam (UPDRS),
  3. Hoehn and Yahr score
  4. Schwab and England Activities of Daily Living Scale
  5. Subject will complete a quality of life survey "Social Roles and Activities"
  6. A video documenting subject walking, standing from sitting, a handwriting sample of one sentence and drawing a spiral will be recorded at each visit beginning with the first infusion visit.
  7. Vital signs monitoring will be initiated (Heart Rate, BP, Resp., Temp., SpO2),
  8. A blood and urine sample for clinical labs (CBC with Platelets, CMP, PT, PTT, complete Urinalysis as well as baseline TNFa, IL6 and CRP)
  9. Assessment for Infusion Related AE/SAEs

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells (HB-adMSCs) for Parkinson's Disease

Resource links provided by the National Library of Medicine



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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. adult individual at least 18 years old
  2. clinical diagnosis of Parkinson's disease
  3. capable and competent to provide informed consent -

Exclusion Criteria:

  1. Prior history of:

    1. Recent or ongoing clinical infection indicated by WBC>13,000 and/or temperature >102.
    2. Clinically significant cardiovascular, lung, renal, hepatic, or endocrine disease or any other acute or chronic medical condition that, in the opinion of the investigator, may increase the risks associated with study participation,
    3. Chemical or ETOH dependency that in the opinion of the investigator would preclude participation in the study
  2. Participation in concurrent interventional research studies during this trial
  3. 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): NCT04064983


Locations
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United States, Texas
Hope Biosciences Stem Cell Research Foundation
Sugar Land, Texas, United States, 77474
Sponsors and Collaborators
Hope Biosciences
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Responsible Party: Hope Biosciences
ClinicalTrials.gov Identifier: NCT04064983    
Other Study ID Numbers: HBPD01
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: July 6, 2021
Last Verified: October 2020
Keywords provided by Hope Biosciences:
movement disorders
neurodegenerative
MSCs
stem cells
brain
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases