Diabetes Clinical Trial - Study Abstract
The Efficacy and Safety of Autologous Fat Stem Cell Transplant
in the Management of Type 1 and Type 2 diabetics.
Studies have claimed that stem cell transplantation may help
type 1 and 2 diabetics through regeneration of destroyed beta cells
in the islets of Langerhans in the pancreas of diabetic patients.
To determine the efficacy and safety of autologous fat stem cell
transplant in the management of type 1 and type 2 diabetics.
Materials and Methods
Uncomplicated Type 1 and Type 2 diabetics who are on either oral
hypoglycemic agents and/ or on insulin with full consent to this
study will be included. Baseline studies in the form of blood
chemistries including Hemoglobin A1C and C-peptide determinations
will be done. When they fulfill the inclusion criteria they will be
subjected to the autologous fat stem cell transplant, a procedure by
which mini-liposuction is done taking 50 cc of fatty tissues from
each side of the abdomen, centrifuging it with acti-stem solution
and infusing it back through the vein to the same patient They
should be willing to undergo the 6-12 month observation period after
the autologous fat stem cell transplantation and the follow-up tests
monthly, 3 months after the transplant and after 6 months which is
the end of the study. They will be maintained on their usual
medications, be it oral hypoglycemic agents or insulin or in
combination till we deemed it to be necessary to stop or discontinue
it. Results: Thirty-seven (37) patients consisting of 4 Type 1 and
33 type 2 diabetics were included in the study. There were 16 males
and 21 females whose age range was 23 to 65 years. Seven were on
pure insulin, 26 on orals and 4 had both insulin and oral
Initial results of 20 Patients Three Months after the Fat Stem
- Initial assessment after 90 days of the first twenty (20)
patients showed a statistically significant improvement in the
FBS/RBS from baseline to Day 7,14,30,60 and 90 resulting into a
decreased Hemoglobin A1C which the most reliable parameter for
- The C-peptide showed a decreasing trend although the sample
size was still too small for analysis.
- The serum triglyceride values likewise showed a significant
- As for the safety parameters, the CBC and blood chemistries
showing kidney and liver functions were not significantly
- There were some patients whose medications be it oral and
insulin were decreased.
- The subjective improvement was remarkable in most of the
patients (90%) with regards to the added vim and vigor,
smoothening of skin and thickening of hair strands (6 patients),
general feeling of well being (12 patients), blood sugars below
100mgs% (4), decreased vaginal pruritus (1), decrease in
nocturia (2), improvement of peripheral neuropathy (2).
These are preliminary results and not until we have reached the 6
months follow-up and have included all the 37 patients as well as
the beneficial effects remain can we only tell that this may be a
revolutionary treatment for diabetes mellitus.