2-year-old lives his best life after groundbreaking spina bifida clinical trial

Tobi looks like your typical 2 year old. He loves to swim, climb, jump on the trampoline and ride his green tractor. He is able to walk independently.

You would never guess this active little boy was diagnosed with myelomeningocele, also known as spina bifida, before birth. But for the past 30 months, he has been part of the CuRe clinical trial, the world’s first stem cell treatment for spina bifida delivered during fetal surgery at UC Davis Health. Spina bifida occurs when spinal tissue fails to fuse properly during the early stages of pregnancy, leading to a range of lifelong cognitive, mobility, urinary and bowel disabilities. It affects 1,500 to 2,000 children in the U.S. every year.

But to Michelle Johnson and Jeff Maginnis, Tobi’s parents, the CuRe trial has given Tobi the very best shot at life and that has made all the difference.

The news that turned their world upside down

At Michelle Johnson’s 20-week ultrasound, she received the distressing news that her developing baby was diagnosed with spina bifida.

This pregnancy was Johnson’s first with her partner Jeff Maginnis. Johnson had a 12-year-old son, Corbin. Maginnis had a 5-year-old daughter, Cameron. The couple, who live in Oregon, were excited to build their new family together.

Suddenly, they were forced to think about wheelchairs and crutches and getting ramps installed into their home.  

“We had no clue of what the fate of that diagnosis would mean for our child,” Johnson said. “But we did know that no matter what happened, we loved this baby and we would do whatever it took to give our baby the best outcome.”

Fetal surgery would be needed to repair the neural tube defect. Johnson’s fetal surgery referral was in process, when she heard about the world’s first FDA-approved human clinical trial using stem cells before birth to treat spina bifida at UC Davis Health. The clinical trial, known formally as the “CuRe Trial: Cellular Therapy for In Utero Repair of Myelomeningocele,” is funded by the state’s stem cell agency, California Institute for Regenerative Medicine (CIRM) and Shriners Children's Northern California.

Johnson applied to participate in the UC Davis clinical trial, knowing that she and Maginnis would need to move to Sacramento for the rest of her pregnancy, if she was accepted. It would mean months of being away from their children, family and friends, her job and the comforts of home.

“I thought of the sacrifice that would go into it and knew that the sacrifice would be worth it to get the best treatment in the world for my baby,” Johnson said.

More screenings, MRI scans and interviews followed. Then she received the life-changing news that she was accepted into the trial. She was the second patient to enroll in the trial.

Second patient receives first-of-its-kind surgery

At 25 weeks gestation, Michelle Johnson had the landmark fetal surgery and stem cell procedure, staffed by a 30-person operating and cell preparation team. Stem cells were placed directly on her fetus’s spinal cord using a special patch to repair the spina bifida defect.

The team generated the specially engineered stem cells for the study in the UC Davis stem cell manufacturing facility according to FDA guidelines. They are produced and screened in a highly specialized facility within UC Davis’s Institute for Regenerative Cures in Sacramento.

The cells were assembled on to the patch, tested for purity and sterility and then hand delivered to the specialized fetal surgery operating room where they were placed directly on the fetal spinal cord at the time of in utero repair.

“Placement of the fetal patch went off without a hitch and mother and fetus did great!” said Diana Farmer, the world’s first woman fetal surgeon, professor and chair of surgery at UC Davis Health and principal investigator on the study. Farmer launched the UC Davis Fetal Care and Treatment Center (FCTC) years ago to help patients like Johnson.

Following surgery, Johnson remained in the hospital for five days, receiving medication to prevent her uterus from contracting and going into preterm labor.

“We prayed and rested and I took the medication. We said that regardless of whether the surgery was a success or not, our baby is still a success,” Johnson said.

Johnson was discharged from the hospital after five days and then returned to the FCTC for ultrasound monitoring.

“We could see the tremendous healing that took place from week to week,” Johnson said. “We could see the reduced hydrocephalus (a condition in which fluid builds up in the brain) in the fetus. We could see the baby’s ankles moving, legs kicking. The progress was evolving. It was just amazing.”

A miracle is born

Johnson’s Caesarean section (C-section) was scheduled at 36 weeks. Throughout the pregnancy, Johnson and Maginnis did not want to find out their baby’s gender until the birth. Johnson’s health care team honored their request and guarded their secret.

And then they got the moment that they had waited for and long prayed for: The healthy cries of their new baby at birth.

“They held down the curtain and held the baby up like ‘The Lion King’ so we could see him. Then Jeff called it: ‘It’s a boy!’” Johnson said.

Their family was complete.

Tobias (Tobi) Marlowe Maginnis was born 7 pounds, 13 ounces and 19 ¾ inches long. He did not have fluid buildup in his brain. He only required IV fluids and oxygen for the first 24 hours after birth. Johnson and her son were discharged from the hospital four days after his birth.

The next chapter

In August 2024, Tobi graduated from in-person follow-up testing phase of the CuRe trial program. He received a certificate for completing all of his assessments and a Build-a-Bear teddy bear with stitching on his spine just like Tobi has on his spine.

Attendees included those from his health care team, who have watched him grow since his birth, as well as fetal surgeon Diana Farmer and bioengineer Aijun Wang, who pioneered this treatment.

The CuRe trial team will continue to follow Tobi until he is 6 years old. 

“I am so thankful to be part of this journey to find a cure for spina bifida for Tobi and for so many others,” Johnson said. “They are advancing medicine at UC Davis Health and Tobi is proof of that.”