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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
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 delivered intravenously for the treatment of Polycystic Ovary Syndrome.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

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

1

Safety: Adverse Events

Clinical monitoring of possible adverse events or complications

Time frame
Four year follow-up

Secondary outcomes

1

Efficacy: Global Improvement Score (GI)

Ranging from 0 to 100%

Time frame
Four year follow-up

Other outcomes

Sponsors and contacts

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