Autologous Intrathecal Hematopoietic Stem Cells — Competitive Intelligence Brief

Autologous Intrathecal Hematopoietic Stem Cells (Autologous Intrathecal Hematopoietic Stem Cells) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Cell therapy. Area: Neurology.

phase 3 Cell therapy Neurology Biologic

Target snapshot

Autologous Intrathecal Hematopoietic Stem Cells (Autologous Intrathecal Hematopoietic Stem Cells) — Hospital Universitario Dr. Jose E. Gonzalez. Autologous hematopoietic stem cells are harvested from the patient, processed, and reinfused intrathecally into the cerebrospinal fluid to promote neural repair and regeneration.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Autologous Intrathecal Hematopoietic Stem Cells TARGET	Autologous Intrathecal Hematopoietic Stem Cells	Hospital Universitario Dr. Jose E. Gonzalez	phase 3	Cell therapy
Casgevy	EXAGAMGLOGENE AUTOTEMCEL		marketed	Autologous genome-edited hematopoietic stem cell therapy	BCL11A	2023-01-01
Cord Blood Cell	Cord Blood Cell	China Spinal Cord Injury Network	marketed	Cell therapy
(H) T-L14	(H) T-L14	National Taiwan University Hospital	marketed	T-cell therapy	T-cells
ACP	ACP	Istituto Ortopedico Rizzoli	marketed	Cell therapy / Regenerative medicine product
3ml-Rejuvinex	3ml-Rejuvinex	Seoul National University Bundang Hospital	marketed	Autologous cell therapy
Licartin and CIK	Licartin and CIK	Tianjin Medical University Cancer Institute and Hospital	marketed	Monoclonal antibody (Licartin); Adoptive cell therapy (CIK)	HAb18G/CD147 antigen (Licartin); Multiple (CIK cells)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Cell therapy class)

1. Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León · 2 drugs in this class
2. Bone Therapeutics S.A · 1 drug in this class
3. DiscGenics, Inc. · 1 drug in this class
4. Celavie Bioscences, LLC · 1 drug in this class
5. China Spinal Cord Injury Network · 1 drug in this class
6. City of Hope Medical Center · 1 drug in this class
7. Brainstorm-Cell Therapeutics · 1 drug in this class
8. Dr. Grant M. Pagdin · 1 drug in this class
9. FDA Office of Orphan Products Development · 1 drug in this class
10. Biosolution Co., Ltd. · 1 drug in this class