Results of a mid-term clinical trial of two cell therapies for acute limb ischemia show similar results

Mid-term results of the first clinical trial were designed specifically to evaluate the safety and efficacy of two cell therapies that show early promise in the treatment of angiitis-induced acute ischemia, released today in STEM CELLS translation therapy. The study, by researchers at Zhongshan Hospital / Fudan University in Shanghai, compared the transfusion of peripheral blood mononuclear cells against the transplantation of purified CD34 + cells in the treatment of this condition.

It both revealed results that yielded satisfactory results and provided evidence for more precise cell therapy implementation under different conditions, the researchers say.

Acute limb ischemia (CLI) is a type of peripheral artery disease caused by severe obstruction in the artery of the lower extremities, which significantly reduces blood flow. Angiitis-induced CLI (AICLI) occurs when the CLI is caused by inflammation in the walls of small blood vessels. This harmful condition leads to severe pain in the legs or toes, even while resting. If left untreated, CLI problems often lead to a reduction.

“There is an increasing proliferation of cells, such as purified CD34 + cells (PCCs), which are multicellular hematopoietic cells, and peripheral blood mononuclear cells (PBMNCs), which are a combination of specific immune cells including T cells, NK cells and more. used as a promising treatment for AICLI, “explained Zhihui Dong, MD, who led the study with Weiguo Fu, MD.” The aim of our trial was to compare medium-term safety and efficacy between the two groups and prove their benefits. “

Between April 2014 and September 2019, 50 AICLI patients were assigned equally to both treatment groups. At the 36-month follow-up, 47 patients remained. The endpoints assessed were primary non-fuel and overall non-fuel survival. At six months after treatment these had been 96 per cent and 84 per cent in the PBMNCs group, and 96 per cent and 72 per cent in the PCCs group, respectively – levels that remained stable at the PBMNCs. times 12- and 24 months, too. The mid-term trial period referred to in this report – 36 months – again confirmed stability.

The group of PCCs had a significantly higher probability of earlier relaxation of pain relief than the group of PBMNCs, while there were significant earlier improvements in Rutherford’s classification (which accounts for seven stages of peripheral artery disease). ) seen in the PBMNCs group. Accordingly, PCCs are preferred for patients with severe pain, while PBMNCs may be a good option for patients with two or more acute ischemic limbs. “

Dr. Weiguo Fu, MD, Researcher

The study further compared the cost-effectiveness of the treatments and found that PCC treatment was less cost-effective compared to PBMNCs treatment, mainly due to the additional cost of the cleansing process. “This finding is interesting and useful for future clinical trials in which we could consider purging PBMNC into PCCs, thereby reducing the cost of trials,” Dr. Dong said. “The next step should be to validate our results in long-term trials involving larger numbers of patients.”

“The results presented in this study of two cell therapies for the AICLI treatment demonstrate both effectiveness and safety,” said Anthony Atala, MD, Managing Editor STEM CELLS translation therapy and director of the Wake Forest Institute for Regenerative Medicine. “This finding is promising and useful for the design of future clinical trials.”