Clinical trial of phase 1/2 to evaluate the feasibility, safety, tolerability and preliminary efficacy of the administration of FAB117-HC, a drug whose active ingredient is HC016, allogeneic adipose derived adult mesenchymal stem cells expanded and pulsed with H2O2, in patients with acute traumatic spinal cord injury.

Phase 1

• Conditions: Patients with acute traumatic spinal cord injury; MedDRA version: 18.1Level: LLTClassification code 10043064Term: T7-T12 level spinal cord injury, unspecifiedSystem Organ Class: 100000004863; MedDRA version: 18.1Level: LLTClassification code 10043046Term: T1-T6 level spinal cord injury, unspecifiedSystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-005717-80-ES
• Lead Sponsor: Ferrer Internacional S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-09
• Last Update Posted: 13 June 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

PHASE 1:
1.Male or female subjects ? 18 to ? 65 years.
2.ASIA A.
3. Spinal Injury with neurological level between D5?D10 (cohorts 1 and 2)
4.Single traumatic spinal cord injury as defined by MRI.
5. Injury occurred between 72 and 120 h before undergoing DSS and treatment.
6.Clinically and haemodynamically stable enough to undergo DSS.
7.Able to give informed consent either in writing or verbally in the presence of a witness.

PHASE 2:
1. Male or female subjects ? 18 to ? 65 years.
2. ASIA A or B.
3. Spinal Injury with neurological level between (D1?D12) (D12 without ZPPM).
4.Single traumatic spinal cord injury as defined by MRI.
5. Injury occurring between 24 and 72h before undergoing DSS and treatment.
6.Clinically and hemodynamically stable enough to undergo DSS.
7.Able to give informed consent either in writing or verbally in the presence of a witness.
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 46
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Research
1.Participation in any clinical investigation within 28 days prior to spinal cord injury or if a cell therapy product has been administrated in the previous five years of SCI

Local
2.MRI or DSS evidence of complete spinal cord transection or equivalent severe lesion or abnormality.
3.Inability to unequivocally identify the injection sites.
4.Multiple injuries to the neurological spinal cord at different levels.
5.Patients with any of these additional conditions:
a.Penetrating spinal cord injuries.
b.Associated trauma or injury to the brachial and / or lumbosacral plexus.
6.Active infection in the surgical area.

Surgical risk and clinical condition
7.Haemodynamic instability contraindicating DSS procedure in the time frame defined for inclusion in the trial.
8.Multiple organ failure.

Neurological
9.Significant head injury (Score on the Glasgow scale less than or equal to 13 and / or abnormal MRI/CT) or other injury that, in the investigator's opinion, is sufficient to interfere with the assessment of spinal cord function or compromise the validity of patient data.
10.Patients undergoing mechanical ventilation that does not allow a prior clinical examination.
11.Inability to communicate with the neurological examiner, so that the validity of patient data could be unreliable.
12.Patients who are unconscious, including those unconscious to require sedative-analgesic medications.

Basal condition and personal clinical history
13.Preexisting or current significant diseases such as hepatitis C, HIV, epilepsy, neoplastic disease or other diseases that could cause neurological deficits, including syphilis, myelopathy, and polyneuropathy.

14. Background or acute episode of Guillain?Barre syndrome.
15. History of meningitis or meningoencephalitis.
16. Current history of autoimmune disease.
17.Patients with uncontrolled blood diathesis or under anticoagulant or antiplatelet pharmacological therapy.
18.Presence of any psychiatric illness, as defined by the DSM-IV-TR, or medically unstable illness which can reasonably be expected to pose an increased risk to on participating in the study, or which causes a significant deterioration of the clinical course of the patient. Secondary depression is expressly excluded.
19. Drug abuse as defined by DSM-IV-TR during the 6 months prior to SCI.
20. Pregnant women.
21. Women who are breastfeeding if unwilling to stop at the time of recruitment.
22. History of life-threatening allergy or immune reaction.
23. Patients with known hypersensitivity to any of the excipients of FAB117-HC.
24. Patients with known or suspected hypersensitivity.to bovine serum, enzymes (trypsin, collagenase type I / II), penicillin, streptomycin or DMSO

Study & Design

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