I want to start this post by saying how thankful I am for doctors like Dr. Ken Moise. He thinks outside of the box and works so hard to come up with new treatment ideas instead of just doing what doctors have done for years. Nora is alive because he helped pioneer the use of plasmapheresis and IVIG to treat pregnant women dealing with alloimmunization/HDFN. He is now working on a new treatment that seems even more effective and groundbreaking than those treatments.
Dr. Moise is working with a pharmaceutical company to develop a new drug that will block all maternal antibodies from going through the placenta and getting to the baby. This treatment is still a few years away from actual use, but thankfully, the FDA has agreed to fast track the drug’s approval process. The drug is being tested right now through a series of safety experiments in pregnant primates. If these studies prove safe for the mother and her fetus they will proceed to studying safety in human volunteers for one month (non-alloimmunized individuals). Hopefully the human trials will start this year (2016.) The first human trial will test whether the drug is safe. After the drug proves to be safe for humans, they will go to the next phase in the safety study and will test alloimmunized women who have completed their child bearing years (they have undergone a tubal or their husband has undergone a vasectomy.) The trial will show if the drug does affect the titer and will help them figure out the dose needed to suppress the antibody level. The final phase would be to give the medication to pregnant alloimmunized patients with a high antibody titer (say greater than 1000) with a history of a pregnancy loss at < 24 weeks. These patients would be monitored in a specialized center with serial MCAs with intrauterine transfusions as a reserve for treatment failures. Hopefully, the new drug will block the maternal antibodies from getting to the baby, which will protect the baby from getting anemic. The only problem with this new drug is the fact that it blocks all maternal antibodies from getting to the baby, even the good antibodies. This is something they are working on now.
The best part of this new treatment (assuming that it works) is the absence of invasive procedures and interventions. The baby won’t need any plasmapheresis, IVIG, or intrauterine blood transfusions to survive. Dr. Moise’s hope is that by the time he retires, he won’t need to teach any younger doctors how to do intrauterine blood transfusions because they will not be needed. Dr. Moise also told me he was hopeful that it would be ready in time for me to have another baby (I am 35 at the moment.) I am praying that this drug works and saves many lives in the future. Ever since I learned that I had anti-Kell antibodies I have been worried about my future grandchildren. Would my son, Asher (who is Kell positive) one day face these same problems with his own wife and children? What about Liam? We don’t know if he’s Kell positive or negative. What about Nora’s sons? Would they grow up and get married only to find out about the “curse” Josh and I have handed down to them? What about Josh’s brother, Caleb, and his wife and kids? These questions haunted me, but because of this new treatment possibility I can relax knowing that in the future a few simple injections during pregnancy could keep these precious babies safe. I’ll keep this page updated with any new information that Dr. Moise shares about the drug and the safety trials along the way.
Very good news! Please keep me posted – I am past child bearing years, age 57, had a high titer. Like you, I am concerned for my future grandchildren. 1 daughter and 1 son are kell positive.
I would absolutely consider participating in the trial! I am 42 have had a tubal. Anything to save a child!
Question: I am kell +, husband kell negative which made it no issue for our natural son but if we were to use an egg donor, does her kell + or – matter since husbands is negative?
Thank you for your blog! I have many questions especially about the treatment you mentioned that one of your Drs have been working on? Do you have an email address or contact details that you would share? Thank you in advance x
Hi April, my email address is email@example.com
Thank you – I have emailed you x
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Has there been any updates on this from Dr. Moise?
Yes, the drug is still in the phase 2 trial stage. It is called Nipocalimab and the trial is called the Unity Study. There will be a phase 3 trial opening up soon. I’m very hopeful that this will be an available treatment option for women in the future! https://globaltrialfinder.janssen.com/trial/CR108980
Thank you for the question and the update! Let’s keep hoping!
Agreed. Major hopes… I do not feel my family is complete and ready for more children. Terrified to proceed with my heterozygous spouse!
Is there any update on this potential treatment?
Thank you for this amazing website!
So sorry for such a delayed response. I haven’t been very consistent with the blog lately since I spend most of my time working with The Allo Hope Foundation, and of course all the wonderful chaos of raising five kids. But to answer your question, yes, the Phase 2 trial for M281 (Nipocalimab) is now finished and they are planning to launch a phase 3 trial sometime next year, I believe. Personally, I’m very excited to see how this progresses and (hopefully) helps other families in the future.