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Stem Cells Shown to Heal Chronic Leg Wounds

Walking on cobblestones

(Kati, Pixabay)

18 September 2017. Experimental treatments using patients’ own stem cells were shown in a pilot test to heal painful chronic wounds on their legs and feet. Results of the study testing a system made by the company InGeneron Inc. in Houston and Munich, appear in the 4 September issue of the Journal of the European Academy of Dermatology and Venereology (paid subscription required).

InGeneron develops regenerative medicine solutions taking advantage of therapeutic properties in an individual’s mesenchymal or adult stem cells that transform into many types of cells, and thus can be harnessed to heal or replace damaged tissue. Using a person’s own stem cells also overcomes problems of immune system rejection from donors, even close family members.

In this case, the stem cells are derived from a person’s adipose or body fat tissue to treat chronic wounds that appear on feet or legs. Among the leading causes of these chronic wounds is diabetes that reduces blood flow to the legs and feet, leading to nerve damage and reduced feeling in those regions, as well as slower healing of wounds. Centers for Disease Control and Prevention says in 2010, some 73,000 Americans required amputation of a leg or foot because of complications from diabetes. While malnutrition and immune deficiencies can also cause chronic wounds, CDC says people with diabetes are 8 times more likely to lose a leg or foot than people without diabetes.

InGeneron is developing its Transpose RT system as a minimally invasive treatment for chronic wounds at the point of care. The system, administered by trained clinicians, removes fat tissue cells, such as those under the skin in the abdomen, similar to liposuction. The system processes the fat cells with enzymes, then heats and isolates adult stem cells from the rest of the mix. Physicians apply the stem cells directly to the wounds in dressings as a topical treatment.

The study team led by Alexander Konstantinow in the Department of Dermatology at Technical University Munich recruited 16 individuals, age 52 to 84, with chronic leg wounds, 7 with venous ulcers and 9 with mixed arterial and venous ulcers. The researchers looked primarily for healing as shown in changes in wound size after 12 weeks, as well as reports of adverse side effects, but also changes in pain experienced and time needed for new tissue to grow in the open wounds. The team follow-up with participants after 6 months.

The results show all 7 participants with venous leg ulcers reporting full closure of their wounds, as well as 4 of the 9 individuals with mixed venous and arterial ulcers, a process taking from 10 to 25 weeks. In addition, participants reported less pain within 2 weeks of treatment. Among the participants, 3 patients had wounds on both legs, but wounds on only one leg were treated. Nonetheless, in these cases the wounds on the non-treated legs also started healing. None of the participants reported serious adverse effects.

InGeneron plans another clinical study in the U.S. with 36 individuals having venous leg ulcers. In this trial, participants will be randomized to receive Transpose RT system treatments or standard wound dressings. The study is now recruiting participants at Sanford Medical Center in Sioux Falls, South Dakota.

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