Q&A With Dr. Eliot Lander on Stem Cell Therapy & Pentosan Liposome Therapy

Dr. Eliot Lander On Stem Cell Therapy For IC

#1 – As the only researcher in the world studying the use of stem cells in the treatment of interstitial cystitis, you have opened a potential new line of therapy. Is your most recent round of data encouraging??

I strongly believe that adult mesenchymal stem cells will have an important role in the mitigation of IC symptoms and healing of damaged tissue. Stem cells help autoimmune disease through immunomodulation (“re-booting” the immune system). Cell therapy also appears to improve chronic pain through its effects on over stimulated afferent pain fibers and cell therapy has shown evidence that it repairs damaged and ulcerated tissue through the mitigation of inflammation and promotion of regeneration. We have treated over 50 patients with their own fat derived stem cells as part of our IRB investigational study and results are very promising but we continue to gather data and it is too early to draw conclusions.

#2 – What symptoms does stem cell therapy appear to help the most? Conversely, what symptoms are not responding to stem cell treatment?

We have seen improvement in symptom and bother scores in most of the patients treated. Visual analog pain scores drop significantly as well in the majority of the patients.

#3 – What specifically do you believe that stem cell therapy is accomplishing in the bladder?? Is it facilitating the regeneration of the bladder wall?? Calming nerves?? Fighting inflammation?

Hopefully all three. We take a holistic approach to cell therapy in that we use some cells systemically to immune modulate since IC seems to have prominent autoimmune features and some cells are injected into the pelvic floor (trigone, peri-urethral, trigger point, etc). We do not currently instill cells into the bladder but they can be injected into Hunner’s lesions cystoscopically if present.

#4 – Is stem cell therapy durable?? If not, how long is the potential benefit before patients require additional treatment.

One of the limitations of cell therapy with chronic degenerative and autoimmune conditions is that patients often require repeat treatment within 1-2 years. We have started a program to freeze a person’s own (autologous) stem cells to address this issue. Frozen stem cells from fat remain healthy indefinitely and these cells can be potentially expanded (grown in quantity) and then deployed over and over again to make repeat treatments more easy and cost effective.

#5 – You harvest stem cells through fat tissue via a liposuction procedure. They are then reintroduced to the body by IV. Have you given any thought to applying the SVF directly into the bladder?? (I apologize if I’ve got this backward… kind of running on empty right now.)

We have learned over the past 5 years that introducing stem cells directly into the bladder lining as a topical instillation is not conducive to cell survival and function. We use our proprietary GAG liposome instillation for the purpose of reestablishing the barrier to help promote healing.

Update on On Elmiron Liposome Therapy

#1 – You’ve been much more excited about your novel application of elmiron into the bladder via the use of liposomes. What is your latest round of research showing?? Effective??

We have always had excellent efficacy with our liposomal pentosan agent in our practice. What has surprised us more than the efficacy is the temporal sustainability in that intravesical liposomal pentosan treatments can have very durable effects and last many times longer (often several weeks) than regular pentosan used as an instillation. This is probably due to the bio-adhesive properties of the liposomes which create prolonged dwell times of the drug which creates a sustained urothelial barrier.

#2 – Because liposomes penetrate easily through the bladder wall, they deliver Elmiron far deeper than when the medication is taken orally. Does this improve the barrier function of the medication?

We believe that we are creating a highly efficient but only topical application and we do not think that there is any significant deep absorption so we have not seen side effects that are common with oral pentosan. We are planning more extensive pharmacokinetic studies.

#3 – Many patients are fearful of catheterization and doing additional bladder instillations. DMSO, for example, can be quite irritating. Is the therapy comfortable?? Do patients feel better after a therapy??

Most patients relate that the agent is “soothing” but as you know with IC, some patients really cannot toler- ate any type of instillation and so this form of therapy may not be suitable for everyone. Our compound uses no alcohol as a preservative and it is balanced to pH 7.4 and carries no other impurities.

#4 – What’s the protocol you are currently using?? Once a week for eight weeks?? Is it possible to use it for a short term, then reassess and, if possible, stop the therapy?

Once a week for 4 weeks, then every other week for 8 weeks and then monthly maintenance is our most common protocol.

#6 – Are patients experiencing the same side effects from Elmiron as they would if taken by mouth?? i.e. hair loss, gut distress, easy bruising, etc.

None of these have been seen in our studies. We published a small case series in 2014 demonstrating excellent safety.

Am J Clin Exp Urol 2014;2(2):145-148 www.ajceu.us /ISSN:2330- 1910/AJCEU0000729

#7 – Elmiron has fallen out of favor as a therapy due, in great part, to a dramatic increase in cost. Would this therapy use less medication thus cost less??

The cost of liposomal pentosan over a 1 year period is similar to or less than oral pentosan (Elmiron). Currently it is available from a compound pharmacy for approximately $125 per instillation. We are hoping to pursue FDA approval and that would permit mass manufacturing that should bring the price down substantially.

#8 – Have you used liposomes to deliver any other medication into the bladder?? Perhaps another coating such as chondroitin or sodium hyaluronate?

The pentosan molecule, like heparin, possesses a high cationic charge, and in view of its extensive safety data, is likely the most effective of the GAG molecules for liposomal use.

#9 – Do you hope to create a new brand and/or seek FDA approval?

Yes- we have been working tirelessly on this for the past 3 years. Our efforts have been well organized however more extensive funding is needed as soon as possible to help get this agent to market.

#10 – Have other  IC clinicians or researchers taken note of your work?? Are any other clinics exploring their use based upon your early data? Has the Ortho Urology / Jannsen Pharma expressed interested in this new, novel use of liposomes?

We have a few groups around the country that are collaborating with us on our stem cell study and many of their patients have also received liposomal pentosan. We have support from several IC experts and key thought leaders from around the country. As far as big pharma,  we’re still waiting to be “discovered.”

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