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ACTIVE NOT RECRUITING
NCT07751640
PHASE1/PHASE2

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

Sponsor: Apeiron Research Center

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

40 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-05-01

Completion Date

2026-09-04

Last Updated

2026-08-07

Healthy Volunteers

No

Interventions

BIOLOGICAL

Autologous Bone Marrow Aspirate (BMA) and Bone Marrow Aspirate Concentrate (BMAC)

Same-day autologous bone marrow aspirate (BMA) administered intravenously and bone marrow aspirate concentrate (BMAC) administered intranasally via mucosal atomization. Both products derived from a single posterior superior iliac spine aspiration. No ex vivo expansion, genetic modification, or cryopreservation performed.

Locations (1)

Boulder Biologics Research Center

Boulder, Colorado, United States