Safety and Preliminary Efficacy of FAB117-HC in Patients With Acute Traumatic Spinal Cord Injury (SPINE)

  • STATUS
    Recruiting
  • End date
    Jul 26, 2023
  • participants needed
    48
  • sponsor
    Ferrer Internacional S.A.
Send
Updated on 27 January 2022
See if I qualify

Summary

The main objective of the study is the evaluation of the safety and tolerability of FAB117-HC (a medicinal product containing human allogeneic adipose derived adult mesenchymal stem cells expanded and pulsed with H2O2, HC016 cells) administered at a single-time point to patients with acute thoracic traumatic spinal cord injury (SCI). The study will also include initial exploration of potential clinical efficacy. Dose levels of 20 million and 40 million cells will be administered.

Description

FAB117-HC is an investigational medicinal product whose active substance is HC016, allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2.

The main purpose of this study is to evaluate the safety and tolerability of a single administration of FAB117-HC using: a) two sequential escalating doses administered between 72 and 120 hours post-injury, to patients with acute traumatic SCI with ASIA Impairment Scale (AIS) grade A; and b) the determined maximum tolerated dose administered up to 96 h post-injury to patients with AIS grading of A or B. The study includes also initial exploration of efficacy.

Treatment is administered by intramedullary injection into the injured spinal cord, during the decompression and stabilization surgery (DSS) of the fracture. DSS is routinely performed on almost all SCI patients.

The study has been divided into two phases:

Phase 1 (open label): 8 AIS A patients with lesion located between D1 and D12 will be included in 2 sequential cohorts.

Phase 2 (randomized, controlled, double-blind): Up to 40 AIS A or B patients with lesion located between D1 and D12, will be randomly divided into two groups (control and treated) that will be balanced in AIS grade.

Details
Condition Acute Traumatic Spinal Cord Injury
Treatment Control group, FAB117-HC
Clinical Study IdentifierNCT02917291
SponsorFerrer Internacional S.A.
Last Modified on27 January 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Phase 1 (2 Cohorts)
Male or female subjects 16 to 70 years
ASIA impairment grade A
Either a level of injury between D1-D12 both inclusive (cohorts 1 and 2)
Single traumatic spinal cord injury as defined by MRI
Injury occurred between 72 and 120h before undergoing DSS and treatment
Clinically and haemodynamically stable, under medical criteria, enough to undergo DSS
Able to give informed consent either in writing or orally in the presence of a witness
Phase 2 (2 Groups)
Male or female subjects 16 to 70 years
ASIA impairment grade A or B
An injury between D1 and D12, both inclusive
Single traumatic spinal cord injury as defined by MRI
Injury occurring up to 96 h before undergoing DSS and treatment
Clinically and haemodynamically stable enough, under medical criteria, to undergo DSS
Able to give informed consent either in writing or orally in the presence of a witness

Exclusion Criteria

Participated in a previous clinical study and received an investigational product within 28 days of SCI (within 5 years of SCI if the investigational product is a cell-based medicine)
Radiological or MRI or DSS evidence of complete or partial spinal cord transection
Inability to unequivocally identify the injection sites
Multiple injuries to the neurological spinal cord at different levels
Patients with any of these additional conditions
Penetrating spinal cord injuries
Associated trauma or injury to the brachial and / or lumbosacral plexus
Active infection in the surgical area
Haemodynamic instability contraindicating DSS procedure in the time frame defined for inclusion in the trial
Multiple organ failure
Severe multiple trauma that hampers the stabilization procedure in the defined term for the inclusion in the trial
Significant head injury (Score on the Glasgow scale less than or equal to 13 and / or abnormal MRI/CT, meaning oedema, axonal lesion and/or haemorrhage) 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
Patients undergoing mechanical ventilation that does not allow a prior clinical examination
Inability to communicate with the neurological examiner so that the validity of patient data could be unreliable
Coma or significant impairment in the level of consciousness, including unconsciousness due to sedative-analgesic medications, that interferes with the performance or interpretation of assessments specific in the protocol
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
Background or acute episode of Guillain-Barre syndrome
History of meningitis or meningoencephalitis
Current autoimmune disease treated with immunosuppressant therapy
Patients with history of severe thrombophilia or under anticoagulant pharmacological therapy which long elimination half-live prevents a rapid transition to heparin (like dabigatran and rivaroxaban)
Presence of any psychiatric illness, as defined by the DSM-IV-TR, or medically unstable illness that means a hindrance to the adherence to rehabilitation and/or to the informed consent signature
Pregnant women or women of childbearing age who are not using an appropriate method of contraception and, moreover, are not willing to continue to use it for the duration of the trial. If the patient is menopausal or sterile, it must be documented in the medical record
Women who are breastfeeding if unwilling to stop at the time of recruitment
History of allergy with anaphylactic shock
Patients with known hypersensitivity to any of the excipients of FAB117-HC
Patients with known hypersensitivity to penicillin, streptomycin, enzymes (trypsin or collagenase), bovine serum or DMSO
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note