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