Administration of autologous adult bone marrow cells expanded in the diffuse axonal injury.

Phase 1

• Conditions: Traumatic cerebral injury, chronically established attributed to diffuse axonal injury.; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-001824-23-ES
• Lead Sponsor: Fundación de Investigación Biomédica del Hospital Universitario Puerta de Hierro-Majadahonda (FIBM-HUPHM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-18
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1) Traumatic brain injury background with cognitive effect and clinical diagnosis of diffuse axonal injury.
2) Clinical scale studies (GCS, NIF, ASHWORTH, GOAT, DRS) as well as neurophysiology and PET-TAC that would allow to have useful baseline values, with the purpose of being able to be compared with the same examinations after the study and obtain objective data of possible efficacy.
3) Aged between 18 and 70 years old.
4) Possibility of follow-up evolution and neuro-rehabilitation support during the follow-up period.
5) Written informed consent according to the current legislation.
6) Hematologic parameters and of creatinine, SGOT and SGPT within normal range according to the laboratory standards, accepting, nonetheless, modifications that are considered not significant in the context of the treatment to be carried out according to the clinical criteria of the research team.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

1) Age below 18 or over 70.
2) Pregnancy or lactation.
3) Patients with systemic disease that is considered by the research team to represent an added risk to the treatment.
4) Alterations in the performed genetic study to rule out risk of cell transformation in the expansion process.
5) Patients with doubts regarding their possible cooperation during the study.
6) Added neurodegenerative disease.
7) Current or past drug addiction or psychiatric disease, as well as current or past cancer disease that may interfere in the study to the investigators' opinion.
8) HIV Positive serology and/or syphillis or allergy to protein products used in the cell expansion process.
9) Active Hepatitis B or Hepatitis C, according to the serology analysis.
10) If in the opinion of the investigator there is some other cause for which the patient is not considered to be a candidate for the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified