HB-adMSCs for the Treatment of Parkinson's Disease
HB-adMSCs for the Treatment of Parkinson's Disease
This Individual Patient Expanded Access IND has been created as requested by an 83-year-old
 man who suffers Parkinson's disease and for which the drugs currently approved are not
 providing an improvement over the progression of this disease.
This is an Individual Patient Expanded Access IND with the primary goal of treatment for an
 individual with Parkinson's Disease. There are no FDA approved, fully restorative treatments
 for Parkinson's Disease. The subject will receive a total of twelve autologous HB-adMSCs
 infusion of 200 million cells.

 Primary Objective:

 1. To evaluate the efficacy of HB- adMSCs by improving activities of daily living in a
 subject with Parkinson's Disease.

 Secondary Objective:

 1. To evaluate the efficacy of HB- adMSCs by improving quality-of-life in a subject with
 Parkinson's Disease.

 2. To assess the safety of multiple administrations of HB-adMSCs in a subject with
 Parkinson's Disease

 7.3. Statistical Measures

 Data analysis will be limited to descriptive statistics of the following:

 -  Incidence and severity of adverse events as measured by CBC, CMP, coagulation panel.

 -  C-reactive protein and Sedimentation rate will be measured to evaluate the ability of
 HBadMSCs to alter Parkinson's Disease related inflammation.

 -  Changes in brain and dopamine availability reflected in PET Scan results.

 -  Changes in motor function as measured by the UPDRS score.

 -  Changes in motor function as documented in video records

 -  Changes in function abilities as measured by the Schwab and England Activities of Daily
 Living score.

 -  Changes in quality-of-life scores as measured by the subject evaluations in the "Social
 Roles and Activities" surveys.

 7.4 Measurement Tools

 -  UPDRS

 -  Neuro-QOL Scale v1.0

 -  Schwab and England Activities of Daily Living score.

 -  Video recordings

 -  Writing Samples

 -  Modified Hoehn and Yahr Staging score

 -  Schwab and England Activities of Daily Living score.
Inclusion Criteria:

 1. Adult individual at least 18 years old

 2. Clinical diagnosis Parkinson's Disease

 3. Subject has provided informed consent before initiation of any study procedure.

 4. Subject has mesenchymal stem cells banked at Hope Biosciences

 Exclusion Criteria:

 1. Clinically significant, uncontrolled 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.

 2. Chemical or ETOH dependency that in the opinion of the investigator would preclude
 participation in the study

 3. Participation in concurrent interventional research studies during this trial

 4. Unwillingness to return for follow-up visits.