Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Versus Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal Injection 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 intrathecal injection of cultured autologous adult adipose derived mesenchymal stem cells versus 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

autologous adipose derived mesenchymal stem cells
Biological/Vaccine
cultured autologous adult adipose derived mesenchymal stem cells
AlloRx
Biological/Vaccine
Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal injection for

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: Treatment GroupExperimental treatment 2 interventions

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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