Apeiron Research Center — Biomedical Watch V2

Traitements2programmes

Essais1liés

Publications2liées

SourceDBlocale

Traitements

2

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Autologous Bone Marrow Aspirate (BMA) and Bone Marrow Aspirate Concentrate (BMAC)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.	Parkinson	Phase 1/2		United States	À vérifier
Autologous Bone Marrow Aspirate (BMA) and Bone Marrow Aspirate Concentrate (BMAC)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.	Parkinson	Phase 1/2		United States	À vérifier

Essais cliniques

1

Molécule	Indication / population	Phase	NCT	Titre	Statut
Autologous Bone Marrow Aspirate (BMA) and Bone Marrow Aspirate Concentrate (BMAC)	Parkinson	Phase 1/2	NCT07751640	Autologous Bone Marrow Aspirate (IV) and Bone Marrow Concentrate (Intranasal) for Parkinson's Disease and Parkinson-Plus Syndromes (SPARC-PD)	ACTIVE_NOT_RECRUITING

Publications

2

Molécule	Indication / population	Titre	Journal	Date
Autologous Bone Marrow Aspirate (BMA) and Bone Marrow Aspirate Concentrate (BMAC)		Surgical Applications for Bone Marrow Aspirate Concentrate.	Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association
Autologous Bone Marrow Aspirate (BMA) and Bone Marrow Aspirate Concentrate (BMAC)		Orthobiologic injections for hip osteoarthritis: A systematic review of clinical outcomes.	Orthopedic reviews