Alliance for Regenerative Medicine - Disease Spotlight

Disease Facts:
Description:
+ Strokes disrupt the
                              Stroke
flow of blood to the          + Leading Cause of Disability in the US
brain, damaging brain
tissue                        Stroke, caused by a disruption in     is estimated that less than 5% of    patients will be treated with its
                              the flow of blood to the brain, is    stroke victims are able to receive   proprietary stem cell product 13-
                              the third most deadly disease in      emergency treatment.                 19 days post-stroke, thus dramati-
Patients:                     the US and the leading cause of                                            cally widening the treatment
                                                                    Even with emergency
+ 795,000 Americans           serious disability. Someone in the                                         window for ischemic stroke. The
                                                                    treatments, stroke often leaves
suffer strokes each year      US has a stroke every 40 seconds,                                          aim of the therapy is to repair and
                                                                    survivors with severe disabilities
 + Stroke is the third        and every three to four minutes,                                           regenerate the brain after an
                                                                    including loss of mobility, pain,
                              someone dies of stroke. When a                                             ischemic stroke and thus reduce
leading cause of death                                              numbness, memory loss,
                              stroke occurs, brain cells begin to                                        patient disability and overall costs
in the US                                                           difficulty talking, and impaired
                              die in a matter of minutes from                                            for caring for these patients.
                                                                    cognitive ability. Stroke victims
                              oxygen deprivation, and over                                               Animal studies have shown that
                                                                    may also lose the ability to care
Cause:                        time damage caused by inflam-                                              Aldagen’s therapy improves
                                                                    for themselves and require a
                              mation and other mechanisms                                                blood flow to the brain and
+ Blood clots or plaque                                             constant caretaker or hospice
                              leaves many patients with                                                  motor function, and reverses the
build-up in the arteries,                                           care, which can be emotionally
                              permanent physical or cognitive                                            decline in cell viability. Athersys,
disrupting the supply of                                            and financially draining for
                              disability. The two most common                                            headquartered in Cleveland, Ohio
                                                                    families. Physical therapy,
blood to the brain            types of stroke are ischemic and                                           is also undergoing a Phase I trial
                                                                    extended hospitalization and
                              hemorrhagic. Ischemic strokes                                              for its product MultiStem®, to
                                                                    long term institutional care
                              account for 87% of the 795,000                                             treat ischemic stroke. Multi-
Cost of care:                                                       required for many victims of
                              strokes that occur in the US every                                         Stem®, is an “off the shelf” cell
+ $73.7 billion in 2010 for                                         stroke represent an enormous
                              year and are caused when a                                                 therapy that has been shown in
                                                                    economic and social burden – the
stroke-related medical        blood clot or other mass in the                                            preclinical models of stroke and
                                                                    American Heart Association
                              arteries severely reduces blood                                            other forms of neurological dam-
                                                                    recently estimated that the
RM and Stroke:                flow to the brain. The onset of                                            age to repair damaged tissue
                                                                    annual aggregate costs of stroke
                              stroke is generally sudden and                                             throughout the body through
+ 8 companies sponsoring                                            exceed $73 billion.
                              without warning. Unfortunately,                                            multiple mechanisms of action,
10 enrolling, ongoing, or     the only non-surgical emergency       The lack of treatment options for    resulting in significant functional
completed clinical trials     treatment available for ischemic      stroke represents an enormous        recovery. The company plans to
studying the use of           stroke must be administered           gap in medical care given its high   initiate a Phase II trial in stroke
autologous or allogeneic      within 3 to 4 hours, and is only      incidence and severity. However,     patients in 2011. Celgene
                              expected to help victims recover      regenerative medicine technolo-      Corporation will also soon
mesenchymal bone
                              more fully, not reverse the           gies are bringing new hope for       conduct a Phase II trial using
marrow cells, neural stem                                           repairing the debilitating effects   placenta-derived stem cells.
                              effects of the stroke. Due to the
cells, and human-placenta     narrow window of intervention, it     of stroke through the use of
                                                                                                         The high incidence of stroke
derived cells to restore                                            living cells and tissues. Several
                                                                                                         globally represents a clear
damaged brain tissue                                                Alliance members have promising
                                                                                                         opportunity for U.S. companies
                                                                    clinical programs in ischemic
                                                                                                         to establish technology
                                                                    stroke. Aldagen, based in North
                                                                                                         leadership to address this global
                                                                    Carolina, is developing a
                                                                                                         health issue. Regenerative
                                                                    regenerative medicine therapy
                                                                                                         medicine therapies currently
                                                                    consisting of autologous (self-
     The Alliance for                                                                                    being developed in the US may
                                                                    donated) stem cells capable of
 Regenerative Medicine                                                                                   be the best hope for the millions
                                                                    improving blood flow to ischemic
                                                                                                         of stroke victims across the world
  (ARM) was formed to                                               tissues. The Company is currently
                                                                                                         faced with a lifetime of disability
  advance regenerative                                              enrolling patients in a Phase II
                                                                                                         and impairment.
medicine by representing                                            trial in which ischemic stroke
   and supporting the
      community of                                            + Regenerative Medicine—In Brief
  companies, academic
                              What is regenerative medicine?        tissue and renew biologic            products addressing many more
  research institutions,
                              Regenerative medicine (RM) is a       function in the body is what         conditions advancing in clinical
patient advocacy groups,      rapidly evolving interdisciplinary    distinguishes RM from other          trials. RM holds the promise of
 foundations, and other       field in health care that trans-      types of treatments and brings       treating a broad range of dis-
organizations before the      lates fundamental knowledge in        new hope for dramatically            eases that collectively represent
    Congress, federal         biology, chemistry and physics        improving clinical outcomes and      a substantial burden to our
agencies and the general      into materials, devices, systems      curing disease.                      healthcare system, including
         public.              and therapeutic strategies,           What diseases can RM treat?          acute and chronic conditions
                              including cell-based therapies,                                            such as diabetes, congestive
                                                                    RM products are currently on
  For more information,       which augment, repair, replace        the market for the treatment of      heart failure, Parkinson’s
 please visit us online at:   or regenerate organs and              wounds, cartilage defects, and       disease, stroke, renal disease,
                              tissues. The ability to repair        diabetic foot ulcers, with           spinal cord injury, and ALS.

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ARM Stroke

  • 1. Alliance for Regenerative Medicine - Disease Spotlight Disease Facts: Description: + Strokes disrupt the Stroke flow of blood to the + Leading Cause of Disability in the US brain, damaging brain tissue Stroke, caused by a disruption in is estimated that less than 5% of patients will be treated with its the flow of blood to the brain, is stroke victims are able to receive proprietary stem cell product 13- the third most deadly disease in emergency treatment. 19 days post-stroke, thus dramati- Patients: the US and the leading cause of cally widening the treatment Even with emergency + 795,000 Americans serious disability. Someone in the window for ischemic stroke. The treatments, stroke often leaves suffer strokes each year US has a stroke every 40 seconds, aim of the therapy is to repair and survivors with severe disabilities + Stroke is the third and every three to four minutes, regenerate the brain after an including loss of mobility, pain, someone dies of stroke. When a ischemic stroke and thus reduce leading cause of death numbness, memory loss, stroke occurs, brain cells begin to patient disability and overall costs in the US difficulty talking, and impaired die in a matter of minutes from for caring for these patients. cognitive ability. Stroke victims oxygen deprivation, and over Animal studies have shown that may also lose the ability to care Cause: time damage caused by inflam- Aldagen’s therapy improves for themselves and require a mation and other mechanisms blood flow to the brain and + Blood clots or plaque constant caretaker or hospice leaves many patients with motor function, and reverses the build-up in the arteries, care, which can be emotionally permanent physical or cognitive decline in cell viability. Athersys, disrupting the supply of and financially draining for disability. The two most common headquartered in Cleveland, Ohio families. Physical therapy, blood to the brain types of stroke are ischemic and is also undergoing a Phase I trial extended hospitalization and hemorrhagic. Ischemic strokes for its product MultiStem®, to long term institutional care account for 87% of the 795,000 treat ischemic stroke. Multi- Cost of care: required for many victims of strokes that occur in the US every Stem®, is an “off the shelf” cell + $73.7 billion in 2010 for stroke represent an enormous year and are caused when a therapy that has been shown in economic and social burden – the stroke-related medical blood clot or other mass in the preclinical models of stroke and American Heart Association arteries severely reduces blood other forms of neurological dam- recently estimated that the RM and Stroke: flow to the brain. The onset of age to repair damaged tissue annual aggregate costs of stroke stroke is generally sudden and throughout the body through + 8 companies sponsoring exceed $73 billion. without warning. Unfortunately, multiple mechanisms of action, 10 enrolling, ongoing, or the only non-surgical emergency The lack of treatment options for resulting in significant functional completed clinical trials treatment available for ischemic stroke represents an enormous recovery. The company plans to studying the use of stroke must be administered gap in medical care given its high initiate a Phase II trial in stroke autologous or allogeneic within 3 to 4 hours, and is only incidence and severity. However, patients in 2011. Celgene expected to help victims recover regenerative medicine technolo- Corporation will also soon mesenchymal bone more fully, not reverse the gies are bringing new hope for conduct a Phase II trial using marrow cells, neural stem repairing the debilitating effects placenta-derived stem cells. effects of the stroke. Due to the cells, and human-placenta narrow window of intervention, it of stroke through the use of The high incidence of stroke derived cells to restore living cells and tissues. Several globally represents a clear damaged brain tissue Alliance members have promising opportunity for U.S. companies clinical programs in ischemic to establish technology stroke. Aldagen, based in North leadership to address this global Carolina, is developing a health issue. Regenerative regenerative medicine therapy medicine therapies currently consisting of autologous (self- The Alliance for being developed in the US may donated) stem cells capable of Regenerative Medicine be the best hope for the millions improving blood flow to ischemic of stroke victims across the world (ARM) was formed to tissues. The Company is currently faced with a lifetime of disability advance regenerative enrolling patients in a Phase II and impairment. medicine by representing trial in which ischemic stroke and supporting the community of + Regenerative Medicine—In Brief companies, academic What is regenerative medicine? tissue and renew biologic products addressing many more research institutions, Regenerative medicine (RM) is a function in the body is what conditions advancing in clinical patient advocacy groups, rapidly evolving interdisciplinary distinguishes RM from other trials. RM holds the promise of foundations, and other field in health care that trans- types of treatments and brings treating a broad range of dis- organizations before the lates fundamental knowledge in new hope for dramatically eases that collectively represent Congress, federal biology, chemistry and physics improving clinical outcomes and a substantial burden to our agencies and the general into materials, devices, systems curing disease. healthcare system, including public. and therapeutic strategies, What diseases can RM treat? acute and chronic conditions including cell-based therapies, such as diabetes, congestive RM products are currently on For more information, which augment, repair, replace the market for the treatment of heart failure, Parkinson’s please visit us online at: or regenerate organs and wounds, cartilage defects, and disease, stroke, renal disease, tissues. The ability to repair diabetic foot ulcers, with spinal cord injury, and ALS.