- Largest prospective clinical study to date on placental
tissue allografts
- Collaboration with
Mölnlycke® Health Care
ROSWELL,
Ga., July 18, 2024 /PRNewswire/ --
StimLabs®, a leading regenerative medicine company,
announced enrollment of the first patient in CAMPSTIM, a
multi-center randomized controlled trial to demonstrate the
clinical outcomes of StimLabs' placental-based tissue products with
standard of care (SOC) compared to SOC alone, in patients with
hard-to-heal diabetic foot ulcers (DFUs). This first patient was
enrolled at Tulsa Wound Center by Dr. Lam Le.
CAMPSTIM employs a novel, modified platform clinical trial
design, marking the first application of such a methodology for
DFUs in the US. Evaluating at least four separate StimLabs
cellular, acellular, and matrix-like products (CAMPs)
– Cogenex®, Revita®,
Enverse®, and Relese® - the study is
managed by the highly experienced SerenaGroup®, led by
Thomas E. Serena, MD, FACS, FACHM,
MAPWCA.
As the largest planned prospective clinical study to date on
placental tissue allografts, CAMPSTIM will enroll approximately 272
patients across multiple sites in the US. The primary endpoint of
the study will be the percentage of target ulcers achieving
complete wound closure in 12 weeks. Secondary endpoints include
time to closure, percentage of wound area reduction, number of
adverse events, and changes in pain and quality of life scores.
"This trial will validate the benefits of our technologies in
supporting patients' wound resolution when added to standard of
care, and enrollment points to the continued progress of the
study," said John Daniel, Founder
and CEO of StimLabs. "The uniqueness of the CAMPSTIM trial design
is recognized by the medical community, and we are pleased to work
with other leaders in wound care, such as
Mölnlycke® Health Care."
StimLabs has collaborated with Mölnlycke Health Care, a leader
in wound care and surgical procedures, to be the exclusive wound
dressing provider for CAMPSTIM. By standardizing the use of
Mepilex® Border Flex, as well as the additional use of
Exufiber® in highly exudating wounds, patients are
treated with a consistent protocol and advanced dressings.
"We are excited to participate in this novel trial and that
these patients will benefit from Mölnlycke's dressings. As a
company dedicated to pioneering radical innovation, we are happy to
support the validation of an approach taking standard of care to
the next level with skin substitutes which will improve clinical
outcomes and benefit patients," says Anders
Andersson, Mölnlycke's EVP of Wound Care.
Diabetes is a well-known, often debilitating, disease affecting
over 38 million people of all ages in the US.1 Each
year 1-4% of these diabetic patients develop a DFU, contributing to
a lifetime incidence of 10-15%.2 DFUs come with serious
risks including skin and soft tissue infections, osteomyelitis,
amputation, sepsis, and death.
Learn more about CAMPSTIM.
About StimLabs
Stimlabs LLC's mission is to advance the state of regenerative
medicine, with a current focus in wound care and surgical
applications. Comprised of industry leaders, StimLabs is dedicated
to offering patients the best possible care while recognizing the
urgency of providing solutions in areas with unmet needs. StimLabs
has a comprehensive product portfolio addressing various clinical
applications and has established a strong intellectual property
catalog. Committed to delivering superior products, StimLabs is a
trusted partner to physicians and patients alike.
stimlabs.com
About Mölnlycke
Mölnlycke Health Care is a world-leading MedTech company that
specialises in innovative solutions for wound care and surgical
procedures. Mölnlycke products and solutions are used daily by
hospitals, health care providers and patients in over 100 countries
around the world. Founded in 1849, Mölnlycke is owned by Investor
AB and headquartered in Sweden.
www.molnlycke.us
1. Centers for Disease Control and Prevention. (2024,
May 15). National Diabetes Statistics
Report. Centers for Disease Control and
Prevention. https://www.cdc.gov/diabetes/php/data-research/index.html
2. Margolis D, Malay DS, Hoffstad OJ, et al. Incidence of diabetic
foot ulcer and lower extremity amputation among Medicare
beneficiaries, 2006 to 2008. Data Points #2. Rockville, MD: Agency for Healthcare Research
and Quality. January 2011. AHRQ
Publication No. 10(11)-EHC009-1-EF.
Patents: http://www.stimlabs.com/patents ©
Stimlabs® LLC; STIMLABS, Revita®,
Enverse®, Relese® and
Cogenex® are trademarks of Stimlabs LLC.
Media Contact:
StimLabs
(470) 616-0958
380532@email4pr.com
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