Announcement

Collapse
No announcement yet.

ChinaSCINet Update

Collapse
This is a sticky topic.
X
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

    Originally posted by Jim View Post
    Yes, a major difference in time!

    When the 27 patients are randomized to the 3 groups (cell transplantation + walking/rehab, cell transplantation + lithium + walking/rehab, walking/rehab only), the therapy will then be available.
    I disagree with that Jim. I would be gobsmacked if the FDA would green light compassionate use whilst the 3 groups are receiving their interventions. They would require safety data from the first US-treated cohort before considering any kind of compassionate use. Are you being overzealous here?

    Comment


      F_P_F, I had the same thought but it is so- "Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA. FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtaining access to human investigational drugs (including biologics) and medical devices."

      http://www.fda.gov/NewsEvents/Public...se/default.htm

      Comment


        Originally posted by Jim View Post
        F_P_F, I had the same thought but it is so- "Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA. FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtaining access to human investigational drugs (including biologics) and medical devices."

        http://www.fda.gov/NewsEvents/Public...se/default.htm
        see http://www.fda.gov/NewsEvents/Public...s_Requirements

        Safety

        • Ensuring patient safety is a priority - FDA must determine that the potential patient benefit justifies the potential risk of the expanded access use of the investigational drug, and that the potential risk is not unreasonable in the context of the disease or condition to be treated. Even with safeguards, there may be significant unknowns about safety and effectiveness.
        • Patients should understand and be willing to accept the possible risks and unknown effectiveness associated with the investigational medical product. Patients generally will need to sign an informed consent form in order to receive the investigational drug.
        • The patient’s physician must determine that the probable risk to the patient from the investigational drug is not greater than the probable risk from the disease or condition.
        Logic suggests that the FDA would find it impossible to determine the risk without the safety data to hand first. You cannot be informed without the safety data. Unless you are suggesting the Chinese safety data will be used for submission.

        Comment


          We were told this would apply to our US IIb Trial, therefore it would have to be based on the safety data of the ChinaSCINet Phase II Trial.

          Comment


            Originally posted by Jim View Post
            We were told this would apply to our US IIb Trial, therefore it would have to be based on the safety data of the ChinaSCINet Phase II Trial.
            Ok. Will be interesting to see whether the FDA would accept the Chinese safety data. Would that be a US-first?

            Comment


              Originally posted by Fly_Pelican_Fly View Post
              Ok. Will be interesting to see whether the FDA would accept the Chinese safety data. Would that be a US-first?
              Great question - I never thought about this, but I also remember compassionate use being for those with life threatening problems (there have beeen good arguments here on CC that argue that SCI is life threatening) hence why some might qualify for compassionate use, with a relaxed attitude around safety - cos it's life threatening.

              But I would also like to know if this would be a first, and if this will hold up either the trial or compassionate use.

              Also Jim, didn't you say after 1 year has lapsed for IIb, that compassionate use applies? That would make sense as that might be enough of a safety window.

              But, you then also said once the trial participants are chosen, that compassionate use will be available.

              Keep up the Good work Dr Wise, Jim and everyone!

              Comment


                Originally posted by Jim View Post
                Actually, they didn't think to include sexual function as an outcome measure. When the subjects are examined for the 3 year follow-up they will ask.
                BTW, sexual function is also controlled by a central pattern generator, so the chances of return are good.

                While an inpatient at the Shepherd Center we were required to take classes that covered SCI sexuality. I would guess that most of the SCI speciality hospitals have the same.
                When you say "return", do you mean getting a hard-on without the use of say, Viagra for example? That probably doesn't include sensation but at least it'll be easier to keep the Mrs happy.

                Comment


                  Originally posted by Barrington314mx View Post
                  When you say "return", do you mean getting a hard-on without the use of say, Viagra for example? That probably doesn't include sensation but at least it'll be easier to keep the Mrs happy.
                  What goes up, must come down

                  Lol anyway, cant wait for a response, especially on FDA approval for compassionate use. It's the weekend so maybe we'll get a reply in the weekday.

                  Comment


                    Sensation, sensation, sensation - surely thats the most important (well to me anyways)
                    Last edited by niallel; 8 May 2016, 2:48 PM.

                    Comment


                      Originally posted by Fly_Pelican_Fly View Post
                      Ok. Will be interesting to see whether the FDA would accept the Chinese safety data. Would that be a US-first?
                      I would think there are many therapies that have been developed around the world and approved by FDA. Not sure at the Phase II stage though. Dr. Young had a pre-IND meeting with the FDA and they accepted the data so it also applies to expanded compassionate use.

                      Originally posted by taymas View Post
                      Great question - I never thought about this, but I also remember compassionate use being for those with life threatening problems (there have beeen good arguments here on CC that argue that SCI is life threatening) hence why some might qualify for compassionate use, with a relaxed attitude around safety - cos it's life threatening.

                      But I would also like to know if this would be a first, and if this will hold up either the trial or compassionate use.

                      Also Jim, didn't you say after 1 year has lapsed for IIb, that compassionate use applies? That would make sense as that might be enough of a safety window.

                      But, you then also said once the trial participants are chosen, that compassionate use will be available.

                      Keep up the Good work Dr Wise, Jim and everyone!
                      Expanded compassionate use, which is new, is available once the subjects are chosen for the phase II. We are told you will be able to apply online and get an answer in 48 hours.

                      Originally posted by Barrington314mx View Post
                      When you say "return", do you mean getting a hard-on without the use of say, Viagra for example? That probably doesn't include sensation but at least it'll be easier to keep the Mrs happy.
                      I am totally speculating because we haven't yet interviewed the trial subjects, but because sexual function is programmed in the spinal cord (CPG) just like walking, bowel, and bladder, it would make sense that it may also return. Money is now being raised to bring the subjects back for complete examinations.

                      Comment


                        Originally posted by Jim View Post
                        I am totally speculating because we haven't yet interviewed the trial subjects, but because sexual function is programmed in the spinal cord (CPG) just like walking, bowel, and bladder, it would make sense that it may also return. Money is now being raised to bring the subjects back for complete examinations.
                        Does this mean it would be just getting it up, no sensation?

                        Have there been any sensory gains with this trial? Apologies if it was mentioned before.

                        Comment


                          Originally posted by niallel View Post
                          Sensation, sensation, sensation - surely thats the most important (well to me anyways)
                          Gawd no. Not without return of function. Can you imagine still needing to cath and feeling everything?

                          Comment


                            Originally posted by Scaper1 View Post
                            Gawd no. Not without return of function. Can you imagine still needing to cath and feeling everything?
                            Aack! Do they make a coude in a French size 2?
                            T3 complete since Sept 2015.

                            Comment


                              Originally posted by Scaper1 View Post
                              Gawd no. Not without return of function. Can you imagine still needing to cath and feeling everything?
                              Hmmm, good point. I would imagine its not such a nice feeling, but wonder how much in comparison to the benefits of getting your rocks off.

                              Seriously I think these are the real things we need to know, not just for this trial but all of them.
                              No one really talks about the practicalities.

                              Comment


                                Congrats! Quick question: Did any quads gain arm and hand dexterity?

                                Comment

                                Working...
                                X