Autologous Bone Marrow Aspirate (IV) and Bone Marrow Concentrate (Intranasal) for Parkinson's Disease and Parkinson-Plus Syndromes (SPARC-PD)

Prior treatment

• Other non-PD/PPS Parkinsonism (e.g., drug-induced, vascular parkinsonism)
• Concurrent enrollment in another PD/PPS study or having taken/received another investigational intervention within 6 weeks of initial screening
• Malignancy diagnosed 2 years prior to initial screening

Other illness

• No strong familial history of PD/PPS not attributable to environmental exposure or any known genetic predisposition to PD/PPS
• Active systemic infection or local infection near the lumbar pelvis region
• History of intracranial or nasopharyngeal surgery deemed detrimental to the participant during the trial, including brain surgery/stereotactic procedure for PD/PPS
• History of electroconvulsive therapy
• Autoimmune disease, including:
  • Rheumatoid Arthritis (RA)
  • Systemic Lupus Erythematosus (SLE)
  • Any disorders of glucocorticoid excess or diseases requiring systemic steroids or immune-modulating therapies
• Cardiac disease deemed significant:
  • Poorly controlled hypertension (BP 140/90)
  • NYHA class III or IV congestive heart failure
  • History of a significant ventricular arrhythmia
• A history of other severe systemic disorders, including significant CVA, TBI, seizure, encephalitis, meningitis, or psychiatric disorder that is deemed potentially harmful to the participant by the PI
• Positive for HIV, HBV, HCV, or syphilis
• Any disorder that compromises the participant's ability to give appropriate informed consent or hinders the ability to perform the assessment and receive the study's interventions
• Any other condition not listed above that is deemed potentially harmful to the participant by the PI

Lab values

• Chronic Kidney Disorder (CKD) \> Stage II or eGFR \<60 mL/min
• Moderate-to-uncontrolled diabetes HbA1c 7%
• Any of the following lab abnormalities:
  • Hematology: Hgb \< 10 g/dl, ANC \< 1.550/L, platelets \< 100,000 /L
  • Chemistry: albumin \< 3.0 g/dL, serum creatine \> 1.5 x ULN, total bilirubin \> 1.5 x ULN, AST/ALT/ALP \> 2.0 x ULN
• Female or another gender who is lactating/breastfeeding or has a positive urine or serum pregnancy test at intake screening

Other

• Unable to maintain/tolerate supine position with cervical neck extension
• Any bone marrow aspiration from the pelvis within 6 months of initial screening
• Any musculoskeletal-pelvis contraindications to BMA harvest from the PSIS
• Obesity class II or higher (BMI 35)
• Osteoporosis
• Female or another gender with childbearing potential not willing to adopt barrier method(s) of contraception, plus one other form, including:
  • Intrauterine system (IUS)
  • Intrauterine device (IUD)
  • Oral, injected, or implanted hormonal contraception

• General:
• Participants diagnosed with PD or PPS by a licensed medical professional
• Documented diagnosis of PD or PPS ≤ 6 years
• Participants with an anticipated survival of at least 3 years in the investigator's opinion
• Participants who are willing and able to give informed consent
• Participants who can comply with the study protocol over the 6-month duration
• Stable medical profile for 60 days prior to the initial intake screening
• Participants can ambulate at least 25m without assistance
• No known history of heparin-induced thrombocytopenia
• Willingness to comply with study requirements and provide informed consent
• Participants have no history of adverse reactions to heparin, e.g., HIT, local numbing medications, adhesives, or skin sterilizing agents
  • PD Inclusion Criteria:
• Idiopathic Parkinson's disease patients who meet the MDS's Clinical Diagnostic Criteria for Parkinson's disease
• Responsive to levodopa or dopamine agonists defined by 33% improvement in "Off"/"On" symptoms by MDS-UPDRS-III
• A modified Hoehn and Yahr stage of 3 or less
• Neuroimaging findings are consistent with PD and absent of atrophy or other brain pathology inconsistent with PD
• "Normal" cognition as assessed by Montreal Cognitive Assessment (MoCA), with a value 26
  • PPS Inclusion Criteria:
  • (DLB)
• High probability of cognitive capacity to give informed consent by the Montreal - Cognitive Assessment (MoCA), with a value 23
• Probable DLB - DLB consortium: Two or more core clinical features are present (including features of parkinsonism for the study), or only one core clinical feature is present, but with one or more indicative biomarkers
• Core clinical features:
  • Fluctuating cognition with pronounced variations in attention and alertness
  • Recurrent visual hallucinations that are typically well-formed and detailed
  • Rapid eye movement (REM) sleep behavior disorder (RBD), which may precede cognitive decline
  • One or more spontaneous cardinal features of parkinsonism: bradykinesia, resting tremor, or rigidity
• Indicative biomarkers:
  • Reduced dopamine transporter uptake in basal ganglia demonstrated by SPECT/PET
  • Abnormal (low uptake) I-MIBG myocardial scintigraphy
  • Polysomnographic confirmation of REM sleep without atonia
  • (PSP)
• MDS Diagnostic Criteria for probable PSP with predominant parkinsonism (PSP-P)
• Ocular motor dysfunction: vertical supranuclear gaze palsy or slow velocity of vertical saccades or frequent macro square wave jerks ("eyelid-opening apraxia")
• Ocular motor dysfunction + akinetic-rigid, axial predominant, levodopa resistant or with tremor and/or asymmetric and/or levodopa responsive (akinesia)
• "Normal" cognition as assessed by Montreal Cognitive Assessment (MoCA), with a value 26
  • (MSA)
• MDS Diagnostic Criteria for clinically probable MSA
• Autonomic dysfunction
• Parkinsonism
• Cerebellar syndrome, including at least one of gait ataxia, limb ataxia, cerebellar dysarthria, or oculomotor features
• "Normal" cognition as assessed by Montreal Cognitive Assessment (MoCA), with a value 26
  • (CBD)
• Chronic progressive course
• Asymmetric onset
• Higher cortical dysfunction: apraxia, speech apraxia, non-fluent aphasia, alien limb phenomena, or cortical sensory loss
• Movement disorder: rigid/akinetic syndrome and either dystonic limb posturing or focal myoclonus in limb, and levodopa-resistant
• "Normal" cognition as assessed by Montreal Cognitive Assessment (MoCA), with a value 26