Fetal Therapy

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Momenta trial

  • 1.  Momenta trial

    Posted 05-08-2019 22:53
    Dear fellow members,

    I recently sent a letter to the SMFM membership regarding the opening of the Momenta clinical trial for severe HDFN (https://clinicaltrials.gov/ct2/show/NCT03842189?cond=HDFN&rank=2) .

    M281 is a unique monoclonal antibody that blocks the FcRn receptor.  This results in a placental blockade of IgG.  Through a secondary mechanism, it will also lower the circulating pool of maternal IgG.

    We are looking for patients prior to 13 weeks gestation with a history of severe HDFN at < 24 weeks gestation in a previous pregnancy (IUT with severe anemia, hydrops with elevated MCA, or fetal demise with confirmatory pathology) secondary to anti-D or anti-Kell.

    Currently we are the only open center here in Houston for the trial although we anticipate 3 - 4 additional US sites opening in the coming months.

    After confirmation of an antigen positive fetus by free fetal DNA, patients will receive weekly infusions of M281 from 14 - 35 weeks gestation at our center.  Travel back home between infusions is allowed and expenses are covered. They must then deliver at our institution and then stay an additional 2 weeks.  All travel and lodging expenses are covered by the trial.

    Let me know if anyone is interested.  My cell is 713-444-7603.

    Thanks

    Ken Moise

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    Kenneth Moise, Jr.
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  • 2.  RE: Momenta trial

    Posted 23 days ago

    How is recruitment going for this trial?

    Jeff



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    Jeffrey Sperling
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  • 3.  RE: Momenta trial

    Posted 23 days ago
    Slow but no safety issues noted to date

    Sent from my iPhone