BladderCell Completes Landmark First-in-Human Clinical Study

BladderCell Completes Landmark First-in-Human Clinical Study

United States, California, Irvine - 07/08/2020 — Data show patients treated with BladderCell non-invasive bioelectric stimulation system improved urinary incontinence symptoms and quality of life.

BladderCell is a medical technology platform within the Leonhardt's Launchpads innovation and startup launch accelerator that has developed a bioelectric stimulation device and signaling software for the treatment of urinary and bowel dysfunction. It has just completed a first in human clinical pilot study and announced results from this study designed to provide a feasibility initial evaluation of the potential safety and efficacy of the BladderCell non-invasive bioelectric treatment system. 

  • At 2 months, 60% percent of all BladderCell-treated subjects were therapy responders and maintained  the benefits after 2 months follow up. There were no serious adverse device-related events or unanticipated device-related events. The pilot results show consistent decreases in symptoms, improvements in quality of life  and patient satisfaction.
  • Results at 3 months demonstrate that responder patients treated with the BladderCell bioelectric system had clinically meaningful improvements in urinary urgency incontinence symptoms and quality of life.

Leslier Miller, M.D., Chief Medical Officer of BladderCell said, “The responder rate from this pilot first in human study is highly encouraging and amongst the highest success rates reported in literature to date from a non-invasive delivery method.  This marks the beginning of a multi-stage careful study plan to more fully confirm sustained safety and efficacy. We will now move forward with a multi-center larger scale study with even more comprehensive followup." 

We plan to present detailed study results at upcoming International Urology meetings, to be announced soon. 

The BladderCell first-in-human early feasibility study was a 30 patient, randomized clinical trial of to evaluate the potential safety and efficacy of the BladderCell bioelectric treatment system in patients with urge incontinence. The intervention period was 8 weeks. There was a 2 months follow-up after the end of treatment to evaluate how long the benefit persists  without ongoing treatment.  Evaluation was performed before the intervention period (pre-intervention), and after the intervention period (post-intervention and follow up) for all participants. Bioelectric Stimulation (BES) effectiveness as a treatment of Lower urinary tract symptoms (LUTS)  was evaluated using the validated questionnaires: PRAFAB-score, OAB-V8, and PGI-I. Participants were randomly assigned to three groups: intravaginal BES (IV), parasacral electo acupuncture (PEA) and percutaneous tibial nerve stimulation (PTNS).  The BES lasted 35 minutes, twice a week for 8 weeks. Regenerative medicine, as delivered via electrical stimulation,  has the potential to provide  the recovery of lost tissue and organ functions. In urology, regenerative medicine approaches include the treatment of lower urinary tract or bladder dysfunction. More studies are needed to confirm safety and efficacy of this non-invasive stimulation approach and proper dosing for optimal results. 

The study was conducted in Porto Allegre, Brazil lead by Dr. Cristiane Carboni and Urologist Dr. Alexandre Fornari, Moinhos de Vento hospital 

Overactive bladder (OAB) includes urinary urge incontinence and urinary frequency and affects an estimated 87 million adults in the United States and Europe. The BladderCell bioelectric therapy is the first treatment to address bladder regeneration via stem cell homing, angiogenesis, muscle and nerve regeneration controlled protein expressions. Electrical stimulation in general has been widely employed to reduce symptoms and restore bladder function and is also employed to treat urinary retention and fecal incontinence. Reimbursement for bioelectric bladder treatment is well established in the United States and is a covered service in Europe, Canada, and Australia.

BladderCell, based in Irvine, Calif., is focused on the development of (1) non-invasive and (2) implantable bioelectric stimulation devices including those for severe advanced cases.   

BladderCell has series of three products in development that are intended to be applied to patients based on the severity of their  bladder dysfunction: 

  1. BladderCell is a non-invasive bioelectric stimulation only system for mild to moderate bladder dysfunction.
  2. BladderCell Plus Lite Biologics is bioelectric + PRF and regenerative fluid therapy for moderate to severe patients.
  3. BladderCell Plus Full Biologics utilizes patented bioelectric stimulation via an implantable micro stimulator, our BC-15  multi-component composition and a re-fillable under skin implantable micro infusion pump intended for use in treating advanced very severe bladder dysfunction.

Bioelectric stimulators in development intended to deliver our patented signals to the target organ include bench top, palm size portable and implantable micro stimulator models. The bench top stimulator was utilized in this pilot feasibility study. 

The core BladderCell technology platform and IP is based on precise bioelectric signaling sequences for stem cell homing via controlled expression of SDF1 and PDGF, new blood vessel growth via a full suite of angiogenic signals, muscle and elasticity regeneration via klotho, COL17A1, tropoelastin and follistatin and nerve regeneration via IGF1 and sonic hedgehog.  For treating highly severe cases we intend to include an implantable and re-fillable micro infusion pump re-filled daily with our proprietary BC-15 multi-component bladder regeneration mixed composition that may be comprised of any or all of these components in combination - hypoxia treated MSC stem cells, adipose tissue derived stromal fraction, endothelial progenitor cells, immature myoblasts,  selected proteins and growth factors, exosomes, PRF, amniotic fluid, nutrient hydrogel, selected alkaloids, Wharton's Jelly, micro RNA gel, DNA methyltransferase 1 (Dnmt1) elastomers and bladder matrix. 

BladderCell has over a 100 related patent claims issued and pending covering its one-of-a-kind technology platform. BladderCell research team members filed the first of our series of  bioelectric urinary regulation patents in 2004 - https://patents.justia.com/patent/20050113879 and since then we have implemented numerous improvements with new patents issued August 13th, 2013 https://bladdercell.com/wp-content/uploads/2019/09/pat8509887_Schuler.pdf and May 12th, 2020  https://patents.justia.com/patent/10646644

The devices used in this study manufactured in Anaheim, California have FDA 510K https://www.accessdata.fda.gov/cdrh_docs/pdf11/K113017.pdf market clearance for improving blood circulation, pain relief and muscle related healing including inflammation management. The specific microcurrent signaling programming for these studies fell within the cleared parameters for this device. Based on only the results of this small pilot study we are NOT making any claims that safety of efficacy has been proven for bladder dysfunction recovery at this time. New larger scale studies are forthcoming. 

BladderCell is collaborating with a number of researchers that have completed independent electrical stimulation bladder recovery studies to improve our knowledge of how best to implement improvements forward.  The product pipeline is still considered to be in development stage. 

About BladderCell:

BladderCell LTP http://www.bladdercell.comis a Licensable Technology Platform with the Leonhardt's Launchpads by Cal-X Stars Business Accelerator, Inc. innovation and startup launch accelerator headquartered in Irvine, California with subsidiary branches in Utah, Brazil, Pittsburgh, Minneapolis and Australia. The BladderCell core research team began stem cell based biologics and bioelectrics research for organ regeneration and healing in the late 1980's.  In 2000 the team began filing the first of a long series of patents for both bioelectric and biologics based organ regeneration and healing.  In 2001 the team treated their first organ regeneration clinical patient with muscle stem cells derived from skeletal muscle.  The first bladder and urinary regulation specific patent claims were filed in 2004 and over 100 related patent claims since have been filed with improvements to the original bladder regeneration and urinary regulation technology platform.  The BladderCell and innovation accelerator business model is to seek out a strategic partner for commercialization after first in human studies have been completed and patents have been issued. 

About Leonhardt's Launchpads:

Leonhardt's Launchpads http://www.leonhardtventures.com is the organ regeneration focused innovation and startup launch accelerator arm of Leonhardt Ventures (Leonhardt Vineyards LLC DBA Leonhardt Ventures).  The Leonhardt team has been developing medtech and biotech inventions and products since the mid 1980s.  The innovation accelerator has over 600 patents claims issued, pending, optioned or exclusively licensed covering bioelectric and biologics based organ regeneration and healing including over 100 patent claims related to bladder regeneration directly or indirectly - https://patents.justia.com/inventor/howard-j-leonhardt

Warning and Disclaimers:  Product(s) are not yet proven safe or effective. Patents pending may not be issued. Patents licensed or optioned may not be maintained. Patents issued may be invalidated or may not be maintained. Products are in early stage development. Forward looking statements may change without notice. As an investment these startups mentioned are in the highest risk category for total loss and only suitable for sophisticated experienced accredited investors. The company does not have on hand sufficient resources to bring these products through clinical studies and certainly not enough resources to bring them fully to market, and may not obtain these resources. The company is underinsured compared to comparable companies on our sector. The company is under staffed and under funded compared to most other participants in this space. Due to a small staff at the accelerator to maintain all web sites and other published materials across over 30 innovation developments they may not be fully up to date and there may be out date inaccurate information. If you have any questions on our products or our company please write us to ask. 

 

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Media Contacts:

Company Name: BladderCell LTP a Leonhardt's Launchpads startup
Full Name: Howard J. Leonhardt
Phone: (424) 291-2133
Email Address: Send Email
Website: www.bladdercell.com