Journal
CYTOTHERAPY
Volume 16, Issue 2, Pages 245-257Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.jcyt.2013.11.011
Keywords
adipose tissue; ASC; cell therapy; CLI; mesenchymal stromal cells
Categories
Funding
- Toulouse University Medical Center [09013547, 10051267]
- Fondation pour la Recherche Medicale (FRM) [JF/GP/LC081117]
- European Community
- Agence Nationale pour la Recherche
- Assistance Publique-Hopitaux de Paris
- Fondation pour la Recherche Medicale
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Background aims. Non-revascularizable critical limb ischemia (CLI) is the most severe stage of peripheral arterial disease, with no therapeutic option. Extensive preclinical studies have demonstrated that adipose-derived stroma cell (AS C) transplantation strongly improves revascularization and tissue perfusion in ischemic limbs. This study, named ACellDREAM, is the first phase I trial to evaluate the feasibility and safety of intramuscular injections of autologous ASC in non-revascularizable CLI patients. Methods. Seven patients were consecutively enrolled, on the basis of the following criteria: (i) lower-limb rest pain or ulcer; (ii) ankle systolic oxygen pressure <50 or 70 mm Hg for non-diabetic and diabetic patients, respectively, or first-toe systolic oxygen pressure <30 mm Hg or 50 mm Hg for non-diabetic and diabetic patients, respectively; (iii) not suitable for revascularization. ASCs from abdominal fat were grown for 2 weeks and were then characterized. Results. More than 200 million cells were obtained, with almost total homogeneity and no karyotype abnormality. The expressions of sternness markers Oct4 and Nanog were very low, whereas expression of telomerase was un-detectable in human ASCs compared with human embryonic stem cells. ASCs (10(8)) were then intramuscularly injected into the ischemic leg of patients, with no complication, as judged by an independent committee. Trans-cutaneous oxygen pressure tended to increase in most patients. Ulcer evolution and wound healing showed improvement. Conclusions. These data demonstrate the feasibility and safety of autologous ASC transplantation in patients with objectively proven CLI not suitable for revascularization. The improved wound healing also supports a putative functional efficiency.
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