Posted by Al Gordon on April 25, 1998 at 14:07:47:
In Reply to: Santa Barbara Diabetes Project posted by colleen kacerosky on April 25, 1998 at 11:42:35:
Colleen,
I wish I knew more about the Santa Barbara Diabetes Project, and I will endeavor to find out. What I do know a little about is a former diabetes project associated with Sansum, a report on which you can see below (I posted this before).
Hopefully when I learn more, I can share your enthusiasm. Right now, I do not have enough information.
Al
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LORAN QUEST
The Loran Medical Systems Quarterly Research Report
"Committed to the Cure of Diabetes"
Vol. I No. I Santa Bar, California
LORAN FETAL TISSUE TRANSPLANT MS BULLETIN
Loran is proud to present its first scientific news bulletin. The bulletin shall be published quarterly and is designed to keep its fetal tissue transplant patients and those diabetics who are considering a transplant, informed as to the results of Loran/IIBM continuing clinical trials program.
The results have been impressive indeed. (see table II) A letter from a patient who under went a transplant in Los Gatos on 10 June 1995 is enclosed as an example of the typical reaction a patient experiences after under going the procedure. This experience, due to differences in physical makeup, may vary somewhat from patient to patient, ie, greater or less insulin reduction, etc., but all appear to be experiencing beneficial
physical changes.
A SHORT HISTORY OF THE PROGRAM
For those of you not familiar with the program, the 1st clinical trial held in the US was a trial arranged by Loran between Sansum Medical Research Foundation and IIBM of Moscow. As most of you are aware, the Russians performed over 3000 fetal tissue transplants during the years when it was not supported by the administration in the US. Based on the success of the Russian experience, an arrangement was made whereby Sansum would furnish 24 US insulin dependent diabetic (IDDM) patients and IIBM specialists would treat them on 30 July 1993 with Russian prepared tissue and treatment procedure. Sansum would then follow the patients for one year and record any changes that might occur as a result of the transplant. Even though the patients, to prove the safety of the procedure to US groups, were only given 3 human fetal pancreata and 18 neonatal rabbit pancreata each, the results were very promising. Over a year later in a formal paper presented before the 2nd International Fetal Tissue Transplant Symposium, the Sansum scientists reported the following statistically significant results:
1. Blood/sugar levels were stabilized in the patients.
2. Not one experienced a severe hypoglycemic attack.
3. Blood pressure was reduced and weight loss occurred.
4. Insulin requirements were reduced by half in some patients and at
least 15% in the
others.
5. No side effects were reported any of these patients.
6. C-peptide levels rose significantly and at the end of a full year
were still at that level in the patients tested. This indicates the
transplant is still working in those patients and shouldcontinue to
work for an as yet unknown period of time.
Remember, these changes occurred in spite of the lesser amount of fetal
tissue transplanted into each patient.
The conclusion, as stated in the Sansum presentation, was that due to the
promising nature of these results, trials should continue by injecting
greater quantities of fetal tissue to increase the beneficial effects of
the procedure. This, of course, had already been done in Russia, but
trials were needed in the US to allay the doubts of the US researchers.
International and US researchers had never experienced this degree of
success without the use of harmful immunosuppression drugs. Doctors in
treating diabetes were therefore limited to merely controlling diet and
insulin intake of their patients. The reason? No treatment, until now, has
been sufficiently proven by clinical trials that would allow them to
recommend treatments that would attack and alleviate the complications of
the disease itself.
The 5 year Diabetes Complications Clinical Trial (DCCT) of the NIH showed
that very tight control of blood/sugar levels could hold off substantially
the onset of complications but the side-effects of this extremely tight
control were increased, ie, 35% more hypoglycemic attacks, weight gain,
and increased risk of infection. An important and serious factor also were
psychological problems caused by the simple fear of severe hypoglycemic
attacks occurring without warning.
It should be noted that the first IIBM trial at Sansum accomplished
everything and more, than the DCCT did, but without any side effects
whatsoever. Therefore, it can be deduced that the stabilizing of
blood/sugars by the Russian treatment program can, as it did in the DCCT,
greatly delay, or stop the onset of complications.
In 1994, considering the promising results of the first trial of 24
patients, Loran in conjunction with IIBM decided to continue trials on its
own. Sansum had dropped their transplant program because no grant money
was available and such non-profit institutions need them to cover the
extremely high costs connected with this form of research. As a result,
their staff has been reduced considerably.Loran looked at the
alternatives, and there were only two: (1) either let this promising
treatment program wait until the government, perhaps in 10 years or so, if
ever, became a little more benevolent with diabetic research funds, or (2)
as many other major research centers are now doing, collect money from the
patients to cover their costs of research projects that have already been
shown by clinical trials to give promising relief to the patient. The
choice was easily made. In the 10 years time it might take for the
government to make up its mind on funding, many diabetics would have
succumbed to complications or would no longer be with us. Some positive
action against this
debilitating disease had to be taken now.
Loran computed the approximate cost of these trials in today's dollars at
roughly $20,000 per patient. It undoubtedly will be increased in the
future as it barely covers expenses now. This cost factor unfortunately
leaves some diabetics out of the program, but those who can afford it are
not only contributing to their own physical welfare but also to those who
someday may have the benefit of insurance to cover their treatment. This
will be awhile but for the present, the patient's monetary contribution is
the only solution available to developing fully the current Loran/IIBM
program.
RESULTS OF CURRENT LORAN/IIBM TRIALS
After the promising results reported in the July 1993 trials with Sansum,
Loran began a new series of clinical trials on 10 June 1995 and has since
completed a total of three trials. A total of 56 patients have been
treated with the last trial completed on 16 Oct 1995. Dr. Bent Formby,
formerly of Sansum and now with Loran, is in charge of patient follow up
from these trials. After initial analysis of the preliminary data from the
lab and the patients' daily diaries, he reports the following:
Trial 11 (10 June 1995) Los Gatos, Calif.
All patients are doing very well. None have reported any signs of adverse
reactions to the transplants. Although we are early in clinical follow-up
procedures, several important changes as summarized in the tables
following have occurred:
1. Blood glucose levels have become significantly stabilized. (See
Table I)
2. Human C-peptide values in plasma have significantly increased by
300% one month after the trial. (C-peptide values indicate the transplant
is already producing insulin within the patient's body.) Accordingly,
insulin requirements have begun decreasing.
3. Patients with neuropathy have reported collective improvement in
their lower extremity peripheralneuropathy symptoms and shooting pains
have abated in their feet during this post-transplant period. The
patients, therefore, are sleeping better at night.
4. One patient who was legally night blind reports her night vision has
improved to the point that she is now driving in the evening.
Trial 111 (5 Aug 1995) Los Gatos, Calif. [The Group Wizop Groves was in]
Again, all patients are doing well with no adverse effects shown. Clinical
data has been received from the lab for about 40% of the patients but it
is not yet complete.
These results so far are extremely encouraging:
1. C-peptide levels have significantly increased >600% in the above
patients.
2. As in the case of Ed Textor, neuropathy improvement has been reported
from those patients with this complication. It is appearing from
patient reports that this complication is the 1st to show improvement
following the transplant.
Trial IV (16 Oct 1995) Los Gatos, Calif.
It is too early to report definitive data from this trial but one patient
has already reported her incisions from a wrist operation have healed as
normal. Prior to
her transplant, even a cat scratch took several months to heal.
Please remember that the data presented from these trials is very
preliminary following the transplant. The major improvements as shown in
the trials in Russia and at Sansum in 1993 appear to occur after 12 to 20
weeks. Please read Ed Textor's letter very carefully and, like Ed, have
patience - Considering past clinical trial results, it is expected that
beneficial changes shall occur in due time.
TABLE I
Indices demonstrating improved glycemic control and drop in insulin
requirement following transplantation of human fetal tissue and neo-natal
rabbit pancreatic microfragments.
Average Daily Blood/Glucose Levels Before and After Transplant)
Before Transplant 2 Mnth After 6 Mnth After Insulin Drop
Group II 258+/- 71 148+/- 52 109+/- 23 10 - 41%
Group III 223+/- 54 133+/- 26 ---- 22 - 38%
Group II - treated 10 Jun 95
Group III - treated 05 Aug 95
Values calculated from patient diaries. Each patient measures values 5 to
7 times per day and faxes or mails results to Loran weekly.
TABLE II
STATUS OF PATIENTS - LORAN/IIBM TRIALS AS OF 9 OCT 1995
TRIALS NO. BLD/GLUCOSE REDUCTION Alc BLOOD C-PEPTIDE MICRO
PATIENTS CONTROL INSULIN PRESSURE INCREASE ALBUMIN
=====================================================================
Trial 1 40%
30 Jul 98 24 Stabilized* 15 to 50% Nrmlzd Nrmlzd Year 1 Reduced
---------------------------------------------------------------------
Trial 11 300%
after
10 Jun 95 10 Stabilized* 10 to 60% Rdcd Nrmlzd 1 month ----
---------------------------------------------------------------------
692%
Trial III after
04 Aug 95 12 Stabilized* 10 to 40% ----- ----- 1 month ----
---------------------------------------------------------------------
Trial IV
16 Oct 95 12 Patients to be treated on 16 Oct 1995
=====================================================================
Note:
6 patients from Trial II have significant reductions in clinical
signs of neuropathy.
7 patients from Trial III have significant reductions in clinical
signs of neuropathy.
(N. Engl J Med 1993;329:977-86) Maintaining blood/glucose concentrations
close to the normal range by intensive therapy effectively delays the
onset and slows the progression of diabetic retinopathy, nephropathy and
neuropathy in patients with Insulin dependent diabetes mellitus. (Diabetic
Complications Clinical Trial)
Unfortunately, the tight control required by the 5 year DCCT study also
increased by two-three fold severe incidence of hypoglycemia, infections
and weight gain. It is significant that the Loran/IIBM trials have
resulted in equivalent or better blood/glucose control, WITHOUT A SINGLE
COMPLICATION. Therefore, applying the results from the DCCT to the
stabilization of blood/glucose levels recorded in the tables above,
complications should be halted in a substantial number of diabetics when
treated by the Russian of fetal tissue transplantation.
=====================================================================
In the first few weeks after our implants, though I was beginning to see
gradual improvements in my average blood sugar levels, the "cautious
optimist" In me maintained that most of the credit for the Improvements
I was seeing was probably due to the extensive monitoring and
fine-tuning of the Insulin dose per the guidelines provided by Dr.
Formby's sliding-scale chart. I reasoned that anyone should show
improvement when they're spending 98 minutes a week doing blood testing.
But in the fifth week, on September 8th, I had my first milestone. This
was We first day, probably in the last 19 years, that my blood sugar did
not exceed 150. 1 still took a "wait and see" attitude, being careful
not to got too excited about it. During the sixth week, I still had
spikes Into the upper 100 and low 200 ranges, but I also had three more
days without exceeding 150. In this same week, I saw my own physician,
and my dietician, the first time since having the transplant. In
reviewing my daily records, they were both very impressed with the slow,
steady improvements that were becoming apparent. Also, my recent
Fructosamine test (used by Kaiser Instead of A1c) showed a level of 270.
Normal is anything below 285, and my physician said it's rare for a
diabetic to be down in this range, I was beginning to be convinced that
the transplant was starting to have an effect.
In weeks seven and eight however, I began to be concerned because my
levels seemed to be creeping back up. I was starting to wonder if the
transplant was beginning to fail, and thinking, "would I be the only one
to have an Immune response and kill-off all of the new. But I kept
plugging along, exercising and eating right. I was hoping that maybe it
was just the rabbit cells beginning to reduce Insulin production, and
the human coils hadn't yet begun to do much work.
Toward the end of week nine, levels seemed to start improving again, and
I had more days of staying under the elusive goal of 150. Yesterday,
October 20th, I reached another milestone. No test exceeded 100.
We haven't reduced my insulin dose yet. But in talking with my doctor,
the real goal here is healthy glucose levels. I'd consider It 100%
successful at this stage, and any dosage reduction will just be a little
added bonus. Neuropathy symptoms in my feet have begun to subside. I no
longer have the jabbing pains and therefore, I'm sleeping much better.
The biggest change noticed by my friendly family and doctors, is in my
positive attitude, and whole outlook for the future. I see a chance of
retiring 20 years from now in normal health. And this feeling of well-
being is priceless.
I'm hoping for the best for everyone in our group. Good luck, God bless
you, and keep-up the good work!
Ed Textor