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Autologous Intrathecal Hematopoietic Stem Cells
Autologous Intrathecal Hematopoietic Stem Cells is a Cell therapy Biologic drug developed by Hospital Universitario Dr. Jose E. Gonzalez. It is currently in Phase 3 development for Spinal cord injury, Amyotrophic lateral sclerosis (ALS).
Autologous hematopoietic stem cells are harvested from the patient, processed, and reinfused intrathecally into the cerebrospinal fluid to promote neural repair and regeneration.
Autologous hematopoietic stem cells are harvested from the patient, processed, and reinfused intrathecally into the cerebrospinal fluid to promote neural repair and regeneration. Used for Spinal cord injury, Amyotrophic lateral sclerosis (ALS).
At a glance
| Generic name | Autologous Intrathecal Hematopoietic Stem Cells |
|---|---|
| Sponsor | Hospital Universitario Dr. Jose E. Gonzalez |
| Drug class | Cell therapy |
| Modality | Biologic |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
This cell therapy involves collecting the patient's own bone marrow-derived hematopoietic stem cells, which are then administered directly into the intrathecal space (around the spinal cord). These stem cells are believed to promote neuroprotection, reduce inflammation, and stimulate endogenous repair mechanisms in neurological tissues. The autologous approach minimizes immunological rejection while leveraging the regenerative potential of stem cells.
Approved indications
- Spinal cord injury
- Amyotrophic lateral sclerosis (ALS)
Common side effects
- Injection site pain or discomfort
- Headache
- Fever
- Infection at injection site
Key clinical trials
- Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia (NA)
- Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation (EARLY_PHASE1)
- Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders (PHASE3)
- Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission (PHASE2)
- Effect of Intrathecal Administration of Hematopoietic Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS) (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Autologous Intrathecal Hematopoietic Stem Cells CI brief — competitive landscape report
- Autologous Intrathecal Hematopoietic Stem Cells updates RSS · CI watch RSS
- Hospital Universitario Dr. Jose E. Gonzalez portfolio CI
Frequently asked questions about Autologous Intrathecal Hematopoietic Stem Cells
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Related
- Drug class: All Cell therapy drugs
- Manufacturer: Hospital Universitario Dr. Jose E. Gonzalez — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Spinal cord injury
- Indication: Drugs for Amyotrophic lateral sclerosis (ALS)
- Compare: Autologous Intrathecal Hematopoietic Stem Cells vs similar drugs
- Pricing: Autologous Intrathecal Hematopoietic Stem Cells cost, discount & access