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Could your own bone marrow cells help fight Parkinson's?
NCT ID NCT07751640
First seen Aug 07, 2026 · Last updated Aug 07, 2026
Summary
This early-stage trial is testing whether a single same-day treatment using a patient's own bone marrow cells is safe and tolerable for people with Parkinson's disease or related conditions. The procedure involves drawing bone marrow from the hip, giving one portion through an IV, and delivering a concentrated portion as a nasal spray. The study also looks at whether the treatment might affect biological age markers in the blood, offering a hint of potential long-term effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A single same-day treatment using the patient's own bone marrow: one part given intravenously and one part concentrated and given as a nasal spray.
- What this could lead to
- If safe and promising, this approach could point toward a new way to ease Parkinson's symptoms or slow the disease by using a patient's own cells.
- What could go wrong
- This is a very early, small pilot study (10 people) focused mainly on safety, not proof of benefit. The treatment may not improve symptoms, and any procedure carries risks like infection or discomfort from the bone marrow draw.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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10 people
The number who actually took part.
- Started
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May 2025
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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 Exclusion Criteria: * Other non-PD/PPS Parkinsonism (e.g., drug-induced, vascular parkinsonism) * No strong familial history of PD/PPS not attributable to environmental exposure or any known genetic predisposition to PD/PPS * Unable to maintain/tolerate supine position with cervical neck extension * Active systemic infection or local infection near the lumbar pelvis region * Any bone marrow aspiration from the pelvis within 6 months of initial screening * Any musculoskeletal-pelvis contraindications to BMA harvest from the PSIS * 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 * 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 * Chronic Kidney Disorder (CKD) \> Stage II or eGFR \<60 mL/min * 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 * Obesity class II or higher (BMI 35) * Moderate-to-uncontrolled diabetes HbA1c 7% * Osteoporosis * 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 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 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 * Female or another gender who is lactating/breastfeeding or has a positive urine or serum pregnancy test at intake screening * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Boulder Biologics Research Center
Boulder, Colorado, 80303, United States
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