Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients
A Phase 3, Randomized Double-Blind, Placebo-Controlled Multicenter Study to Evaluate Efficacy and Safety of Repeated Administration of NurOwn® (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors) in Participants With ALS
Doctors in CA, MA, and MN seek ALS patients to participate in a trial exploring the safety and efficacy of a treatment, NurOwn®, a bone marrow transplant made from the patient’s own (autologous) stem cells. The treatment will draw stem cells from the patient’s bone and be modified and multiplied in a lab to produce before being injected into the patient’s spinal fluid through an intrathecal (spinal) injection. The modification prepares the stem cells to work in a “neuroprotective” manner, producing molecules that repair and protect neurons and reduce inflammation.
The trial first requires harvesting of bone marrow stem cells, then 3 intrathecal administrations of NurOwn® at bi-monthly intervals treatment every 3 months for a total of 4 intrathecal injections over 12 months. Half the participants will receive placebo injections, and all will be followed for up to 20 weeks post transplant.
- Be 18 years to 60 years of age
- Have a diagnosis of ALS and onset of ALS disease symptoms, including limb weakness within 24 months at the Screening Visit.
- Not have received a prior stem cell transplant
- Not be pregnant or breastfeeding
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility of the patient to participate.
- Mesenchymal stem cells will be drawn from the patient’s bone marrow, typically via the iliac crest or ridge of the hip.
- After the stem cells are amplified in the lab (over a period of weeks), the patient will return to receive a single dose of the stem cells via spinal injection 3 months for a total of 4 intrathecal injections over 12 months.
- Follow up will continue for at least 20 weeks post the treatment
LOCATIONS AND CONTACTS:
Contact: Ralph Z. Kern, MD | 201-488-0460 | [email protected]
Contact: Yael D. Gothelf, Ph.D | [email protected]
The study sites include:
University of California Irvine Alpha Stem Cell Clinic in Irvine, CA. Map.
Cedars-Sinai Medical Center in Los Angeles, CA.. Map.
California Pacific Medical Center in San Francisco, CA. Map.
Massachusetts General Hospital in Boston, MA. Map.
University of Massachusetts Medical School in Worcester, MA. Map.
Mayo Clinic in Rochester, MN. Map.
Michelle M Turner | [email protected] | 507-284-2676
Carol Denny | [email protected] | 507-284-2676
California Institute for Regenerative Medicine (CIRM)
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