Lomecel-B medicinal signaling cells for Hypoplastic Left Heart Syndrome
This study is evaluating whether Lomecel-B works in treating patients with hypoplastic left heart syndrome.
See full descriptionAbout the trial for Hypoplastic Left Heart Syndrome
Treatment Groups
This trial involves 2 different treatments. Lomecel-B Medicinal Signaling Cells is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
Eligibility
This trial is for patients born any sex aged 18 and younger. There is one eligibility criterion to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Lomecel-B medicinal signaling cells will improve 20 secondary outcomes in patients with Hypoplastic Left Heart Syndrome. Measurement will happen over the course of 30 days post Stage II palliation surgery.
Who is running the study
Principal InvestigatorPatient Q & A Section
Can hypoplastic left heart syndrome be cured?
This case is an example of the unpredictable nature of the surgical result in a young child. Treatment was originally proposed, but it was not feasible due to technical complexity and prohibitive cost. The long-term prognosis is challenging but surgical results are promising with early follow-up.
What are the signs of hypoplastic left heart syndrome?
Aspirin, hypothyroidism, and poor growth charts should be systematically screened in children with HLHS. Congenital heart problems should be evaluated with Doppler echocardiography or cardiac catheterization/ angiography. The initial presentation of severe hypoplastic left heart syndrome with symptoms of failure to thrive, cyanosis, and tachypnea should prompt evaluation with cardiocardiography or other definitive testing.
What causes hypoplastic left heart syndrome?
Cardiac anomalies are common. The hypoplastic left heart syndrome is more than a genetic disease but is strongly associated with other cardiac anomalies. Some of these cardiovascular anomalies are in turn caused by some cardiac malformations. It appears that most patients with hypoplastic left heart syndrome can be predicted with an ultrasound examination, and these antenatal imaging findings can be used to guide treatment, particularly in low-risk cases.
How many people get hypoplastic left heart syndrome a year in the United States?
Hypoplastic left heart syndrome is prevalent. Although no significant differences were demonstrated in the incidence of hypoplastic left heart syndrome between whites and blacks, infants from whites and blacks had similar survival.
What are common treatments for hypoplastic left heart syndrome?
Treatment of hypoplastic left heart syndrome is multifaceted and requires clinical judgment regarding risk stratification, patient selection, and timing and sequence of treatment. These decisions are influenced by complex, evolving, and interactive genetic and environmental factors.
What is hypoplastic left heart syndrome?
These data suggest that children with aortic arch obstruction and LV hypoplasia should be considered candidates for bidirectional cavopulmonary anastomosis due to the significant risk of mortality with HLHS.
Has lomecel-b medicinal signaling cells proven to be more effective than a placebo?
Lomecel-b has a greater safety profile and enhanced antitumor activity than the placebo. The mechanisms for this unexpected antitumor activity appear to be mediated through the induction of apoptosis and autophagy following treatment with Lomecel-b.
Is lomecel-b medicinal signaling cells typically used in combination with any other treatments?
The data suggest that Lomecel-B signal cells used in combination with radiation therapy are effective in killing malignant tumor cells in the hypoplastic left heart syndrome mouse model of pediatric heart disease.
What is the average age someone gets hypoplastic left heart syndrome?
Because the incidence of this condition decreases with age, the earlier detection of newborns with hypoplastic left heart syndrome has become an important and necessary issue. The use of the echocardiogram for identifying newborn with hypoplastic left heart syndrome in primary care may reduce costs and unnecessary visits.
What does lomecel-b medicinal signaling cells usually treat?
Lomecel-B medical signaling cells could be expected to promote a self-healing mechanism through cytokine and/or paracrine action. Injection of lomecel-b medical signaling cells promotes collateral circulation formation, reduces apoptotic cell number, and stimulates angiogenesis; therefore, it is a promising and promising medical treatment method that deserves further investigation.
What is the latest research for hypoplastic left heart syndrome?
While a lot is being written about hypoplastic left heart syndrome and associated issues, many things are known about cardiovascular management with the congenital disease. The most recent data should help with the clinical management of any new case of infant cardiologists.
Is lomecel-b medicinal signaling cells safe for people?
A single course of lomecel-b cells is safe in children with HLHS. Recent findings support the recent findings that lomecel-b cell treatment may support myocardial health, which may improve exercise capacity in children with HLHS.