Isolation, Cryopreservation and Culture of Human Amnion Epithelial Cells for Clinical Applications

Murphy, Sean V.; Kidyoor, Amritha; Reid, Tanya; Atala, Anthony; Wallace, Euan; Lim, Rebecca

doi:10.3791/52085-v

Cited by 1 publication

(2 citation statements)

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“…hAEC were isolated as described previously. 9 Purity was assessed by flow cytometry using EpCam + cells (BD Biosciences). Batches that were >90% EpCam-positive but <1% positive for MSC markers (CD90 and CD105) were cryopreserved in 5% human serum albumin and 5% DMSO.…”

Section: Methodsmentioning

confidence: 99%

“… 8 Regarding their potential for clinical use, compared to hundreds of thousands of mesenchymal stromal cells (MSC) that can be isolated from adipose tissue or bone marrow, 120–200 million hAEC are routinely isolated from a single term amnion using a method that is free of animal products and compliant with clinical use. 9 The isolation process for hAEC is approximately 4-6 hours compared to MSC that require 4-6 weeks of ex vivo expansion to obtain a similar number of cells for therapeutic use, making hAEC a low-cost and abundant cell resource. Moreover, hAEC pose no ethical concerns as the placenta is normally discarded following delivery.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Human Amniotic Epithelial Cell Transplantation is Safe and Well Tolerated in Patients with Compensated Cirrhosis: A First-in-Human Trial

Lim,

Hodge,

Warner

et al. 2024

Stem Cells Translational Medicine

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Placenta-derived human amniotic epithelial cells (hAEC) exhibit anti-inflammatory and anti-fibrotic effects in cirrhosis models. We conducted a first-in-human phase I clinical trial to assess the safety and tolerability of hAEC in adults with compensated cirrhosis. We examined increasing and repeated doses of hAEC in 9 patients in 3 cohorts. Cohort 1 patients received 0.5 × 106/kg hAEC in one IV infusion. Cohort 2 patients received 1 × 106/kg hAEC in one IV infusion. The patients in cohort 3 received 1 × 106/kg hAEC on days 0 and 28. Here, we report follow-up to post-infusion day 56 (D56), during which no serious adverse events occurred. Six patients experienced no study-related adverse events, while 3 patients reported mild (grade 1) headaches that were possibly infusion-related. A transient decrease in serum platelet count occurred in all patients, which returned to baseline screening values by day 5. FIB-4 values to assess fibrosis were significantly lower at D56. Although not statistically significant, serum AST levels and liver stiffness measurements at D56 were lower than those at baseline. The hepatic venous pressure gradient, a measure of portal hypertension, declined in 4 patients, did not change in 3 patients, and increased in 2 patients. In conclusion, intravenous infusion of allogeneic hAEC in patients with compensated cirrhosis at the doses used in this study was safe and well tolerated, with no difference observed between 1 and 2 doses. Decreased hepatic inflammation, liver stiffness, and portal hypertension support larger studies aimed at identifying patients who may benefit from this therapy. Clinical Trial registration: The trial was prospectively entered on the Australian Clinical Trials Registry (ANZCTR12616000437460).

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%