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Multiple Sclerosis Relapse Study- PDA001

TItle: A Phase 1B, Randomized, Placebo Controlled, Multiple Dose Study to Evaluate the Safety of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults with Multiple Sclerosis

Purpose: Primary objective is to evaluate the safety and tolerability of Human Placenta-Derived Cells administered IV to patients with relapsing remitting MS or secondary Progressive MS. Infusion of placental derived stem cells (from full-term live births, donated by parents) occurs on two occasions, 1 week apart and then the patient is follow closely for 2 years. Patients do no need to stop current disease modifying treatment.

Who Can Participate?

Diagnosis or Condition: Patients with relapsing remitting or secondary progressive Multiple Sclerosis with relapse in last year

Age: 18 to 65 years old

Able to walk with at least canes or walker (EDSS of 6.5 or less)

Progression or continued relapses or worsening of MRI after at least 1 year of attempted therapy

No changed in disease modifying therapy for 3 months prior to dosing

Sex: Males and Females

Visits: 14 visits with extended follow-up for up to 2 years.

Stipend: You will be compensated for your time and travel

Principal Investigator: John R. Huddleston, MD, FAAN

Study Coordinator: Sandra Reilley, MD, CPI, 253.403.7440

For more information, contact the Study Coordinator and reference Celgene Trial.