Autologous Bone Marrow Aspirate (IV) and Bone Marrow Concentrate (Intranasal) for Parkinson's Disease and Parkinson-Plus Syndromes (SPARC-PD)
Public ClinicalTrials.gov record NCT07751640. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Single-Arm, Open-Label, Within-Subject Pilot Study (Phase I/IIa) Evaluating the Safety, Tolerability, and Exploratory Epigenetic Outcomes of a Single Same-Day Administration of Autologous Bone Marrow Aspirate (Intravenous) and Autologous Bone Marrow Aspirate Concentrate (Intranasal) in Adults With Parkinson's Disease or Parkinson-Plus Syndromes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07751640
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 10 participants
Conditions and interventions
Interventions
Biological
Eligibility (public fields only)
- Age range
- 40 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2025
- Primary completion
- Sep 3, 2026
- Completion
- Sep 3, 2026
- Last update posted
- Aug 6, 2026
2025 – 2026
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Boulder Biologics Research Center | Boulder | Colorado | 80303 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07751640, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 6, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07751640 live on ClinicalTrials.gov.