Abstract
These studies were designed to define the growth promoting and immunogenic potential of aggregated hGH contained in clinical grade hGH1 used in the therapy of hGH deficient children. Samples of clinical grade hGH were fractionated into aggregated and monomeric components by Sephadex gel filtration. The absorbance at 280 ran of the gel filtration fractions indicated that various lots of clinical grade hGH contained between 38.4-60.9% polymeric hGH (P1), 29.6-12.8% dimeric hGH (P2) and 26.3-43% monomeric hGH (P3). The radioimmunoreactivity of P1, P2 and P3 was 5, 30 and 100% of an hGH standard, respectively. One group of patients receiving clinical grade hGH (2 U, M-W-F) had growth rates of 1.6±0.3 and 8.1±0.6 cm/yr before and during therapy, respectively. A second group of patients receiving an amount of P3 (monomeric hGH) contained in 2 U of clinical grade hGH (28.2% P3) had growth rates of 1.6±0.6 and 10.9±0.6 cm/yr before and during therapy, respectively. Antibodies to monomeric hGH were detected in sera of 54% of the first group and in 0% of the second group of patients within 9 months of onset of therapy. We conclude that 1) the growth promoting potential of clinical grade hGH resides solely in the monomeric hGH fraction, and 2) aggregated hGH stimulates formation of antibodies to monomeric hGH during therapy with clinical grade hGH. 1Clinical grade hGH was generously supplied by NIAMDD, NIH and National Pituitary Agency.
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