---
title: Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis
nct_id: NCT00855400
overall_status: COMPLETED
phase: PHASE1, PHASE2
sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
study_type: INTERVENTIONAL
primary_condition: Amyotrophic Lateral Sclerosis
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00855400.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00855400"
ct_last_update_post_date: 2010-12-02
last_seen_at: "2026-05-12T07:19:35.732Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis

**Official Title:** Phase I/II Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis

**NCT ID:** [NCT00855400](https://clinicaltrials.gov/study/NCT00855400)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 11
- **Lead Sponsor:** Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- **Collaborators:** Carlos III Health Institute, Hospital Universitario Virgen de la Arrixaca, Hospital General Universitario Morales Meseguer, Diógenes Foundation
- **Conditions:** Amyotrophic Lateral Sclerosis
- **Start Date:** 2007-02
- **Completion Date:** 2010-02
- **CT.gov Last Update:** 2010-12-02

## Brief Summary

The purpose of this clinical trial is to asses the feasibility and the security of the intraspinal infusion of autologous bone marrow stem cells for the treatment of Amyotrophic Lateral Sclerosis patients.

## Detailed Description

Patients with Amyotrophic Lateral Sclerosis (ALS) typically endure a progressive paralysis due to the continued loss of motoneurons that leads them to death in less than 5 years. No treatment has changed its natural history. Intraspinal injections of bone marrow mononuclear cells (MNC) have been able to ameliorate the course of ALS in murine models, acting as pumps of trophic factors that keep the motoneurons functional. We have designed a phase I/II clinical trial to check the feasibility of this approach in humans.

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Diagnose established following the World Federation of Neurology criteria
* More than 6 and less than 36 months of evolution of the disease
* Medullar onset of the disease
* More than 20 and less than 65 years old
* Forced Vital Capacity equal or superior to 50%
* Total time of oxygen saturation \<90% inferior to 2% of the sleeping time
* Signed informed consent

Exclusion Criteria:

* Neurological or psychiatric concomitant disease
* Need of parenteral or enteral nutrition through percutaneous endoscopic gastrostomy or nasogastric tube
* Concomitant systemic disease
* Treatment with corticosteroids, immunoglobulins or immunosuppressors during the last 12 months
* Inclusion in other clinical trials
* Unability to understand the informed consent
```

## Arms

- **Transplant** (EXPERIMENTAL) — T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation

## Interventions

- **Laminectomy and bone marrow stem cells transplantation** (PROCEDURE) — T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation
- **Autologous bone marrow cells collection** (PROCEDURE) — Autologous bone marrow cells collection under sedation. Sixty mL are obtained and processed through a ficoll gradient.

## Primary Outcomes

- **Forced vital capacity** _(time frame: Every 3 months)_

## Secondary Outcomes

- **ALS-FRS, MRC and Norris scales** _(time frame: Every 3 months)_
- **Absence of adverse events** _(time frame: Every week / month depending on the study phase)_

## Locations (1)

- Hospital Universitario Virgen de la Arrixaca, El Palmar, Murcia, Spain

## Recent Field Changes (last 30 days)

- `sponsor.collaborators` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital universitario virgen de la arrixaca|el palmar|murcia|spain` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00855400.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00855400*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*