GERN got the go-ahead, they had...
1) Problems in preclinical trials - cysts at injection sites, ACT has had no microscopic or gross indications of tumor formation.
2) Gern's using a cocktail therapy consisting of several different types of stem cells. If purity is the FDA's concern, then how could a cocktail of different cell types be more pure than ACT's single cell therapy? ACT's purity level is as close to perfect as anything in this world can be.
3) Gern is working on the spine which could lead to possible migration of stem cells to other areas of the body. Many doctors have voiced their opinion that the 'eye' would be a better first case study - its enclosed and immune priveleged.
4) Both Gern and ACT are using the same method of administration - a needle.
5) ACT has studies in several animal species - mice, rat, and swine - Gern has only mice, which other doctors have voiced their concern over stating the studies should have included other species and larger species.
ACT has done as well as, or surpassed Gern in about every aspect for IND approval. We shall see in about a week whether the FDA has been infiltrated by those who wish to see the company fail. It's the only reason I can conceive the FDA would not allow this human trial to begin.