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NCT06858254Not yet recruitingPhase 1/2

Standard Optimization of Stem Cells in Parkinson's Disease and Atypical Parkinsonism

Standard Optimization of Autologous Stem Cells by Intranasal and Intravenous Administration to Treat Parkinson's Disease and Atypical Parkinsonism

Source: ClinicalTrials.gov · Last updated 5 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The purpose of this study is to measure outcomes using intranasal and intravenous autologous bone marrow mesenchymal stem cells (BM-MSCs) for Parkinson Disease (PD) and Parkinson's Plus (PPS) patients.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
19 Feb 2025
Start date
1 Apr 2025
Primary completion date
Apr 2028
Lead sponsor
Apeiron Research Center
NCT number
NCT06858254

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 60
  • From 1 Apr 2025 to the primary completion date, Apr 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

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
  • Unable to receive/tolerate neuroimaging (e.g., MRI-incompatible cardiac pacemaker)
  • 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

Criteria the registry did not label

  • General Inclusion Criteria:
  • Participants aged 40-75 years old with a diagnosis of PD or PPS (DLB, PSP, MSA, CBD with parkinsonism) based upon clinical criteria and standardized testing
  • Participants time of documented PD or PPS is \</= 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 18-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
    • 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
  • 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

Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.