Health Trials

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell IV Infusion for Systemic Sclerosis

ConditionSystemic Sclerosis
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 intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Systemic Sclerosis

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of Systemic Sclerosis

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 GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety (adverse events)

Clinical monitoring of possible adverse events or complications

Time frame
Four year follow-up

Secondary outcomes

1

Efficacy: skin score

It will be completed for each follow up point.

Time frame
Four year follow-up
2

Efficacy: Forced vital capacity (FVC)

It will be completed for each follow up point.

Time frame
Four year follow-up

Other outcomes

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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