A first in human clinical study of TT101, a synthetic immunomodulatory material to build new functional tissue over exposed bone as a one time treatment for diabetic limb preservation patients

Ended Project Grant Awarded Last action

Award ID
R44DK130778
Recipient
Awarding agency
Obligated
$6,467,082

Award facts

Completion date
Originally
Funding
  • $5,098,992.00 Federal
  • $1,368,090.00 Non-federal
Place of performance
California, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
According to the united states centers for disease control, 34 million americans have diabetes. One of the most prevalent complications of diabetes is the diabetic foot ulcer (DFU). Approximately 25% of diabetics will develop a non-healing foot ulcer in their lifetime. Dfus are highly susceptible to infection and tissue necrosis that require extreme surgical interventions to remove extensive dead tissue and preserve the limb. Unfortunately, tissue damage is often so extensive that these surgical procedures leave behind complex wounds with exposed bone, tendon, and or fascia - which are notoriously difficult to heal and where current bioengineered skin products do not have benefit. Indeed, foot ulceration is the most common single precursor of lower extremity amputations among persons with diabetes and is a precursor to approximately 85% of the lower extremity amputations within this population - exceeding 100K every year in the US alone. Furthermore, reported mortality rates for DFU patients range from 55 to 74% after 5 years, which are above cancers such as prostate, breast, and colon. The current treatment options for complex wounds are scarce. Bioengineered skin sheets are unable to build new tissue over these exposed bone surfaces, and basic wound care has little effect as well. Negative pressure wound therapy (NPWT) has shown improved healing, but this management tool requires intensive outpatient care and is cumbersome. There is a clear need for a regenerative therapy that can have effect in the 'vertical' phase of wound healing, where building new tissue volume is paramount to success. This significant clinical need creates a considerable market opportunity. To answer this market need, tempo therapeutics has developed the map wound matrix - a flowable synthetic tissue scaffold based on our proprietary microporous annealed particle (map) technology. Map wound matrix is flowable (ease of application) and fills wounds of any shapes and sizes, and then converts to a hyper-porous sponge-like network in the wound site after exposure to white light. The hyper-porosity geometry promotes fast granulation tissue, and early vascularization, when compared to leading decellularized tissue-based matrices, with minimal inflammatory response in multiple animal models including diabetic pigs. Unlike most of these matrices, map does not require multiple applications. Tempo has already completed the necessary studies to support clinical trial application to FDA with safety and performance data and has completed initial scale-up of product manufacturing. In the proposed direct-to-phase II work, we will pursue the development of map wound matrix and conduct a multicenter, randomized pilot clinical study to evaluate its efficacy and safety to treat complex wounds in diabetic patients. Successful completion of this study will bring clinical evidence of the performance of map wound matrix as well as crucial information to set the next larger clinical study in order to drive adoption in wound care industry.

Transactions

Action Federal Non-federal Date
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Quick answers

Who received award R44DK130778?

R44DK130778 was awarded to Tempo Therapeutics, Inc. by National Institute of Diabetes and Digestive and Kidney Diseases (National Institutes of Health) on September 15, 2021.

How much is award R44DK130778 worth?

$6,467,082 has been obligated on R44DK130778: $5,098,992 in federal funding and $1,368,090 in non-federal funding.

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