← Back to Search

Regenerative Therapy

Amnioinfusion for Pulmonary Hypoplasia Due to Renal Conditions

Q: Are there any vacancies still available to take part in this experiment?

Affirmative. Records on clinicaltrials.gov confirm that this medical research, which was first published on October 1st 2018, is actively recruiting volunteers. 40 individuals must be recruited from a single site.

Q: Is the FDA sanctioning Lactated Ringers Solution for Injection?

Due to the Phase 1 classification of Lactated Ringers Solution for Injection, our team at Power has assigned a score of 1 when assessing its safety. This rating is based on limited data that demonstrates efficacy and proves the drug's security.

Q: How many participants have opted to partake in this clinical trial thus far?

Affirmative. The clinical trial hosted on the website is currently recruiting for 40 patients to participate at a single site. It was initially posted in October 2018 and last updated in May 2022.

Phase 1

Recruiting

Led By Mauro Schenone, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Fetus < 26 weeks gestational age with severe LUTO and intrauterine renal failure

Fetus with absence of chromosome abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial will test whether serial amnioinfusions can help fetuses with either severe LUTO or bilateral renal agenesis by reducing the severity of pulmonary hypoplasia.

Who is the study for?

This trial is for pregnant women over 18 with a single fetus under 26 weeks old, diagnosed with severe LUTO and renal failure or bilateral renal agenesis. The fetus must not have chromosome abnormalities or associated anomalies, and the mother should test negative for Hepatitis B, C, and HIV. Women at high risk of preterm labor or with certain medical conditions are excluded.Check my eligibility

What is being tested?

The study tests whether injecting Lactated Ringers Solution into the amniotic fluid can help regenerate lung function in fetuses with kidney issues leading to low amniotic fluid levels. This could increase their survival chances after birth to start dialysis treatments.See study design

What are the potential side effects?

While specific side effects are not listed here, interventions like serial amnioinfusions may carry risks such as infection, premature labor, or discomfort at the injection site for the mother.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My unborn baby has severe urinary tract obstruction and kidney failure before 26 weeks.

Select...

My unborn baby does not have any chromosome abnormalities.

Select...

I am over 18 years old.

Select...

My unborn baby has no kidneys and is less than 26 weeks old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Secondary outcome measures

Survival to dialysis

Survival to renal transplant

Trial Design

1Treatment groups

Experimental Treatment

Group I: AmnioinfusionExperimental Treatment1 Intervention

Lactated Ringers Solution for Injection --- Serial ultrasound-guided amnioinfusion procedures will be performed on fetuses having severe LUTO or bilateral renal agenesis that are diagnosed between 18 0/7-25 6/7 weeks.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,766,112 Total Patients Enrolled

Mauro Schenone, MDPrincipal InvestigatorMayo Clinic

4 Previous Clinical Trials

220 Total Patients Enrolled

Media Library

Serial Amnioinfusions (Regenerative Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03723564 — Phase 1

Congenital Renal Failure Research Study Groups: Amnioinfusion

Congenital Renal Failure Clinical Trial 2023: Serial Amnioinfusions Highlights & Side Effects. Trial Name: NCT03723564 — Phase 1

Serial Amnioinfusions (Regenerative Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03723564 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies still available to take part in this experiment?

"Affirmative. Records on clinicaltrials.gov confirm that this medical research, which was first published on October 1st 2018, is actively recruiting volunteers. 40 individuals must be recruited from a single site."

Answered by AI

Is the FDA sanctioning Lactated Ringers Solution for Injection?

"Due to the Phase 1 classification of Lactated Ringers Solution for Injection, our team at Power has assigned a score of 1 when assessing its safety. This rating is based on limited data that demonstrates efficacy and proves the drug's security."

Answered by AI

How many participants have opted to partake in this clinical trial thus far?

"Affirmative. The clinical trial hosted on the website is currently recruiting for 40 patients to participate at a single site. It was initially posted in October 2018 and last updated in May 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia

Mauro H. Schenone 2018. "Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03723564.