Safety and efficacy assessment of cord blood mesenchymal stromal cells in chronic cervical spinal cord injury

Phase 1

• Conditions: Cronic traumatic spinal cord injury; MedDRA version: 20.1Level: PTClassification code 10041554Term: Spinal cord injury cervicalSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-000346-18-ES
• Lead Sponsor: Banc de Sang i Teixits

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-11
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1.Single spinal cord injury lesion caused by trauma
2.Affected cord segments between C1 and T1, confirmed by magnetic resonance
3.Incomplete lesion (ASIA B, C or D)
4.Chronic disease state (between 1 and 5 years after the injury)
5.Patients from 18 to 70 years of age, both sexes
6.Life expectancy > 2 years
7.Residence near the center during study participation and confidence that the patient will attend the follow-up visits
8.Given informed consent in writing
9.Patient is able to understand the study and its procedures
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 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

1.Mechanic ventilation
2.Penetrating trauma affecting the spinal cord
3.Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
4.Planned spinal surgery within subsequent 12 month after entering the trial
5.Neurodegenerative diseases
6.Significant abnormal laboratory tests that contraindicates patient's participation in the study
7.Neoplasia within the previous 5 years, or without complete remission
8.Patient with communication difficulties
9.Simultaneous participation in another clinical trial or treated with an investigational medicinal product the previous 30 days, that could interfere in the results of the study
10.Previous treatment with and advanced Therapy Medicinal Product (cell therapy)
11.Contraindication for lumbar punction
12.Contraindication or inability to follow a rehabilitation program
13. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
14.The patient does not accept to be followed-up for a period that could exceed the clinical trial length

(*) Allowed anticonceptive methods are: hormones, intrauterine dispositive, barrier methods, voluntarily sterilization or menopause >1year duration.

Study & Design

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