Phase 1/2 Clinical Trial Results Positive for SpinalCyte’s CybroCell™ Dermal Fibroblasts

Landmark Human Trial Suggests Treatment Could Eliminate Need for
Opioids in Some Patients

HOUSTON–(BUSINESS WIRE)–#cybrocell–Degenerative disc disease has long been considered an inevitable part of
aging, but new breakthrough research from SpinalCyte,
, a Texas-based regenerative medicine company focused on
regrowth of the spinal disc nucleus using human dermal fibroblasts
(HDFs), suggests a new cell-based therapy could provide a cure for
millions of sufferers. SpinalCyte has completed the first double blind,
placebo-controlled human trial using HDF injections to treat sufferers
of degenerative disc disease.

Almost 70 percent of patients who were treated with the first
off-the-shelf allogeneic HDF product for treatment of degenerative disc
disease, called CybroCell, reported significant therapeutic improvement.
Prior research has shown that intradiscal injection of CybroCell
resulted in significant increase in regeneration, disc height, gene
expression of structural genes such as collagen type I and collagen type
II, and the contents of structural proteins such as proteoglycan, which
in turn generate the jelly-like material (disc nucleus) that provides
cushioning for the spine1.

“CybroCell, in my opinion is the future of cell therapy,” said
SpinalCyte Chief Scientific Officer Thomas Ichim, Ph.D. “The current
data suggests that CybroCell has the ability to significantly reduce
pain, improve patient quality of life and be more effective than
conventional stem cells. It has the added benefit of being more
economical to produce and easier to acquire. Compared to all of the stem
cells that I have worked with in my career, fibroblasts used in
CybroCell are much superior.”

The landmark Phase 1/2 trial included 16 patients with chronic lower
back pain caused by degenerative disc disease. The patients were
randomly assigned to one of three groups. The first group received a
placebo in the form of saline only; the second group received a single
intradiscal injection of 10 million cells of CybroCell and the third
group received a single intradiscal injection of 10 million cells of
CybroCell in combination with platelet-rich plasma (PRP).

Using the Oswestry Disability Index (ODI), a widely used questionnaire
measuring the intensity and disabling effect of lower back pain on daily
activities, researchers determined that the ODI of four of the six
patients (67 percent) treated with CybroCell decreased by more than 15
points, which is considered a significant therapeutic improvement. One
of the four patients (25 percent) treated with CybroCell in combination
with platelet-rich plasma (PRP) reported an ODI decrease of more than 15
points while one of six patients (17 percent) in the placebo group
reported an ODI decrease of more than 15 points.

“The U.S. opioid crisis is a national emergency, so we consider the
development of CybroCell, which may reduce or eliminate the need for
opioids among patients suffering from chronic back pain as a result of
degenerative disc disease, to be an urgent public health priority,” said
Pete O’Heeron, Chief Executive Officer, SpinalCyte. “Chronic lower back
pain effects nearly 33 million Americans and over 7 million are related
to degenerative disc disease 2. This creates a national
crisis for their quality of life. Our human trials exceeded our most
optimistic projections and we believe it will ultimately lead to a cure
for degenerative disc disease. On behalf of everyone at SpinalCyte, I
would like to thank the patients and physicians who participated in our
Phase 1/Phase 2 trial and let them know we are committed to advancing
this novel approach so all patients can benefit.”

SpinalCyte’s Phase 1/2 trial is the first allogeneic use of fibroblasts
outside of skin conditions. Considering how relatively easy it is to
collect large numbers of fibroblasts, researchers believe this trial
will advance the clinical translation of fibroblasts into other areas of
regenerative medicine.

Photo available for download:

About SpinalCyte, LLC

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine
company developing an innovative solution for spinal nucleus replacement
using human dermal fibroblasts. Currently, SpinalCyte holds 25 U.S. and
international issued patents and has filed for an additional 48 patents
pending. Funded entirely by angel investors, SpinalCyte represents the
next generation of medical advancement in biologics.

1Chee et al. Cell Therapy with Human Dermal Fibroblasts
Enhances Intervertebral Disk Repair and Decreases Inflammation in the
Rabbit Model.
Spine J.
2016 Dec;6(8):771-779.



SpinalCyte, LLC
Investor Contact:

Daniel Keeney, APR, 832.467.2904