Ensayos clínicos

Inclusion Criteria:

• ≥ 18 years of age.
• Second or third trimester of healthy pregnancy.
• Meet all tissue donor eligibility criteria (as defined by 21 CFR 1271 donor eligibility criteria).
• Planning to deliver her infant at Mayo Clinic Rochester via Cesarean Section.
• Able and willing to provide written informed consent.

Exclusion Criteria:

• Failure to meet 21 CFR 1271 donor eligibility criteria based on responses to a Tissue Donor History Questionnaire (administered at the time of enrollment), including but not limited to: history of malignancy (including melanoma and any form of other skin cancer <6 months from diagnosis*), transplant, long-term use of steroids, autoimmune disorders, or chronic infections such as HIV, Hepatitis, TB, MRSA etc.
• Positive infectious disease result on any test in the infectious disease screening panel collected during Visit 1 or post-operatively with the exception of CMV** (including HBsAg Screen, HBc Total Ab, HBV NAT, HCV NAT, HIV-1 NAT, HCV Ab Screen, HIV-1/-2, plus O Ab Screen, HTLV-I/-II Ab Screen, T. cruzi Total Ab, Syphilis Ab Screen, West Nile Virus NAT, ZIKA NAT).
• Abnormal pregnancy that may include:
  • Birth defects of the fetus;
  • Maternal complications with the placenta or umbilical cord anatomy;
  • Any complications during the birthing process.
• Vaginal delivery.
• Excluded after medical records review or physical exam.

NOTE: Enrolled subjects will be excluded from the study if, at the time of delivery, any of the below occur. In these situations, tissue and cord blood will not be collected, and the subject will be withdrawn from the study. Tissue will be given to clinical pathology for review post-delivery as standard procedure.

Exclusion Criteria Post Enrollment:   

• Placentas with Apgar test < 7 at 5 minutes.
• Gestation period of < 37 weeks.
• Multiple gestation (twins or greater).
• Suspected chorioamnionitis.
• Time between membrane rupture and delivery > 18 hours.
• Any significant fetal medical history including: stillborn, respiratory distress, ominous heart tracing, fetal anomaly, oligohydramnios, transfer to NICU, and IUG.
• Any significant maternal medical history including: recurrent reproductive complications, unexplained maternal fever, collagen vascular disease, hypertension/preeclampsia, diabetes, and substance abuse.
• Unusual anatomic findings (placental mass, true knots, or unusual findings per the obstetrician).
• SARS-CoV-2 (COVID-19) infection during pregnancy.

* Melanoma is excluded, any skin cancer diagnosis > 6 months from resection is acceptable.

**Donors who test positive for CMV will remain eligible for participation. Should MSCs and/or derivatives of be successfully isolated and included in the biorepository, a disclaimer disclosing positive CMV status of the tissue donor will be included on the Certificate of Analysis for future considerations. 

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/5/23. Questions regarding updates should be directed to the study team contact.