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

Running, not enrolling · Phase 1/Phase 2 · Has a placebo group

Conditions studied: PARKINSON DISEASE (Disorder), Atypical Parkinsonism

In brief

This pilot study evaluated the safety, tolerability, and exploratory epigenetic outcomes of a single same-day autologous bone marrow procedure in adults with Parkinson's disease (PD) or Parkinson-plus syndromes (PPS). Ten participants underwent posterior superior iliac spine bone marrow aspiration under local anesthesia. The unprocessed aspirate (BMA) was filtered and administered intravenously via normal saline infusion on the same day. A portion of the aspirate was centrifuged to produce a bone marrow aspirate concentrate (BMAC), which was atomized intranasally using a mucosal atomization device. Cells were not expanded in culture or genetically modified. The procedure was performed under the Same Surgical Procedure exception (21 CFR 1271.15(b)); an investigational new drug application (IND 31770) was submitted to the FDA Center for Biologics Evaluation and Research (CBER). The primary outcome was safety and tolerability, assessed by treatment-emergent adverse events (TEAEs) graded per CTCAE v5.0 criteria through 12 months post-treatment. Exploratory outcomes included DNA methylation biological age (GrimAge-based composite and organ/system Systems Age clocks) measured from peripheral blood at baseline and approximately 6 months, and characterization of the delivered cell product by automated hematology and multiparameter flow cytometry.

Key facts

Study ID

NCT07751640

Run by

Apeiron Research Center

People needed

10

Starts

2025-05-01

Expected to finish

2026-09-04

Last updated by the study team

2026-08-07

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:

Where it is running

• Boulder Biologics Research Center — Boulder, Colorado, United States

Full record on ClinicalTrials.gov

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