An Open-label, Single-arm, Phase-1 Clinical study to evaluate the safety of purified Human Chorionic Gonadotrophin in patients with acute Graft vs Host disease

Human chorionic Gonadotrophin is nature’s anti-rejection agent. In normal pregnancy

regulatory T-cells are increased in number both at the fetal-maternal interface and in the

peripheral blood due to HCG[7]. Commercially available urinary hcg are also sources

of Epidermal Growth Factor(EGF)[8]. In pre-clinical models of intestinal damage due

to radiation use, EGF has been shown to enhance gut epithelial regeneration and protect

against the development of colitis[9]. Two studies are available with the use of HCG in

GVHD one of them is a pilot study with the use of low-dose HCG and the other is a

phase-1/2 study by et al which determined a maximum tolerated dose of 2000U/m².In

the phase-2 study by Holton et al even though their pre-determined dose in phase-1 is

2000IU/m²they have used 5000 IU/m²in cases of steroid refractory GVHD as the EGF

response was inadequate. In two other pilot studies[10], [11] in oncology where uHCG

is used for immunomodulation doses used were 10,000 IU i.m, daily for 8 weeks, 1-

3,00,000 IU for 3-4 weeks with no serious adverse events.Hence there is a need for a

well-structured dose-finding study for the optimal use of the therapeutic effect of

uHCG.