Reviewers Comments and Questions (on the) Revised Protocol - " the Therapeutic Effect of Total Body Irradiation Followed by Infusion of Autologous or Isologous Marrow in Humans " by E Silberstei..

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ation followed by infusion of auto logo us or iso logo us marrow Reviewers Comments and Questions Some explanation of the first protocol would bc3y pro pri ate develop severe thr ombo cyto peni a and leukopenia whereas it hz c been Should not this protocol be explicit on each of thc first four items in this list which are not covered by a protocol ? What is the significance of the future work planned ? There is no rationale given for the sequence of event5described.Will these things be do ce without submission of another protocol ? The protocol entitled, "An evaluation of thc therapeutic effect of total body irradiation in humaxis" cannot bt: judged because it ir; incomplete.Xo information is given concerning the therapeutic ef: a protocol,some data should be given as to why the therapeutic mud - packs could be given to the controls ; he has as much infor = c : f . about their effectiveness as that of5 - flu or uracil. interested in kno ving hot: the survival rates with body rai ict ion conducted so farc or. ? are with patients given in the literature w j - out treatment andr hose of patients receiving ken other a ? y . Twc:- five cz sese relisted in the appended table. f!ave they been SCI.

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.Me recognize that the investigators are2ware of the e notional towards their information,but rather to them s chan is z used to inform the patient of complications of this sort of3rote c tion fro = his en vi ronne nt.Possibly,they are not actually going to use the life island,or never have. If they are to use one,I think one needs to consider the possibility of gaining informed consent for such a procedure,difficult though it be. * What is the risk of embolism associated vith the infusion of What procedures have been used to define the presence or absence of intra vascular clotting and lor embolism associated vith this Rather than take myself to the library to read the long list of references given,I would appreciate it if the investigators would sun ma rize the experience of other groups vith ? this procedure with b) complications of infusion of mar rou,such as en bol is m c)the survival data obtained by others using I note that in the voluntary consent statement,there is a statement with regard t o risk that the " only cells affected which would cause any risk toyou are those in yo;r bone marrow". This is an exclusion of fact,and perhaps should be modified.