Boost Brittle Bones Before Birth (BOOSTB4)

  • STATUS
    Recruiting
  • End date
    Aug 12, 2033
  • participants needed
    30
  • sponsor
    Karolinska Institutet
Updated on 15 February 2022
col1a2
col1a1

Summary

An exploratory, open label, multiple dose, multicentre phase I/II trial evaluating safety and efficacy of postnatal or prenatal and postnatal administration of allogeneic expanded fetal mesenchymal stem cells for the treatment of severe Osteogenesis Imperfecta compared with a combination of historical and untreated prospective controls.

Details
Condition Osteogenesis Imperfecta
Treatment BOOST cells
Clinical Study IdentifierNCT03706482
SponsorKarolinska Institutet
Last Modified on15 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The exclusion criteria, except exclusion criterium 2, 3, 4 and 5 for the postnatal group apply
Prenatal inclusion: The exclusion criteria, except exclusion criterium 1, 4, 5, 6 and 7 for the prenatal group apply

Exclusion Criteria

Existence of other known disorder that might interfere with the treatment, such as, but not limited to organ dysfunction (for example liver or renal failure or bronchopulmonary dysplasia), congenital heart defect, hypoxic encephalopathy l-lll, severe neurological problems, immune deficiencies, muscle diseases, severe malformations or syndromes diagnosed by clinical examination
Any contraindication for invasive procedures such as a moderate/severe bleeding tendency
Known risk factors for clotting, such as, but not limited to previous blood clot, family history of clots, clotting disorder (inherited or acquired), heart failure, inflammatory disorders (for example lupus, rheumatoid arthritis, inflammatory bowel disease)
Positive Donor Specific Antibody-test
Known allergy/hypersensitivity to Fungizone and/or Gensumycin
Abnormal karyotype or other confirmed genetic syndromes
Oncologic disease (previous or current malignancy)
Inability to comply with the trial protocol and follow-up schedule
Inability to understand the information and to provide informed consent
Exclusion Criteria Prenatal Group
Multiple pregnancy
Co-existence of other disorder that might interfere with the treatment, as judged by the Investigator or the patient's obstetrician
Abnormal fetal karyotype or other confirmed genetic syndrome
Any contraindication for invasive procedures such as a bleeding tendency or contagious infections, such as, but not limited to HIV, Syphilis, Hepatitis B, Hepatitis C or other known infectious diseases that can harm the fetus
Known risk factors for clotting, such as, but not limited to previous blood clot, family history of clots, clotting disorder (inherited or acquired), heart failure, inflammatory disorders (for example lupus, rheumatoid arthritis, inflammatory bowel disease)
Positive Donor Specific Antibody-test
Known allergy/hypersensitivity to Fungizone and/or Gensumycin
Oncologic disease in woman or fetus (previous or current malignancy)
Unwilling to or cannot undergo delivery by elective Caesarean section
Inability to comply with the trial protocol and follow-up schedule
Inability to understand the information and to provide informed consent
Exclusion Criteria Historical Control Group
Existence of other disorder that might interfere with the trial
Abnormal karyotype
Exclusion Criteria Prospective Untreated Control Group
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note