Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for SCI

ConditionSpinal Cord Injuries

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorThe Foundation for Orthopaedics and Regenerative Medicine

About this trial

This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Spinal Cord Injury.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of Spinal Cord Injury

Understanding and willingness to sign a written informed consent document

Disqualifiers

Active infection

Active cancer

Chronic multisystem organ failure

Pregnancy

Trial design

Design model

Single group

Treatments tested in this trial

AlloRx
Biological/Vaccine
cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Treatment Group (AlloRx)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Safety (adverse events)

Clinical monitoring of possible adverse events or complications

Time frame

Four year follow-up

Secondary outcomes

Efficacy: American Spinal Injury Association Impairment Scale (ASIA)

It will be completed for each follow up point

Time frame

Four year follow-up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Foundation for Orthopaedics and Regenerative Medicine

Lead sponsor

Source ClinicalTrials.gov

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