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New Long-Term study Proposes PuCeT Therapy as an Effective Treatment for AICLI

Review of “A Five‐Year Study of the Efficacy of Purified CD34+ Cell Therapy for Angiitis‐Induced No‐Option Critical Limb Ischemia” from STEM CELLS Translational Medicine by Stuart P. Atkinson

While advancements in endovascular and surgical reconstruction have improved outcomes in patients suffering from critical limb ischemia (CLI), a classic vascular disease caused by various etiologies, certain CLI patients suffer from conditions that make standard treatment options unfeasible (no‐option CLI) [1]. Of note, patients suffering from angiitis‐induced critical limb ischemia (AICLI) represent a significant proportion of no-option CLI patients.

Encouragingly, a pilot study [2] led by Zhihui Dong and Weiguo Fu (Zhongshan Hospital affiliated to Fudan University, Shanghai, China) suggested that purified CD34+ cell transplantation (PuCeT) therapy [3, 4] may represent an exciting new treatment option for AICLI. Now, the team returns in STEM CELLS Translational Medicine with the results of their extension to their pilot study that aimed to evaluate the long‐term efficacy of PuCeT in AICLI patients [5].

Fang et al. enrolled 27 AICLI patients from May 2009 to December 2011 into their new trial and collected CD34+ cells from peripheral blood following a 5-day treatment with granulocyte colony‐stimulating factor (G‐CSF) to enhance the mobilization of stem cells from the bone marrow. Following purification and transplantation by intramuscular injection, the study followed each patient over a 5‐year follow‐up period. 

Encouragingly, the authors reported an ~89% major‐amputation‐free survival rate, an increase in pain‐free walking time, a reduction in pain scores, an ulcer healing rate of ~86%, a recurrence rate of ~11 %, a significant improvement in patient’s functional health and well-being, and a labor recovery rate of ~65%. Furthermore, the study observed no serious side effects related to the treatment, suggesting that PuCeT therapy represents a safe and durable treatment option for AICLI.

The authors hope to soon confirm the encouraging conclusions from this study through further long-term studies of PuCeT therapy with a larger cohort of AICLI patients.

For the results of all the new studies and more on the potential of PuCeT therapy for critical limb ischemia, stay tuned to the Stem Cells Portal!


  1. Norgren L, Hiatt WR, Dormandy JA, et al., Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg 2007;45 Suppl S:S5-67.
  2. Dong Z, Chen B, Fu W, et al., Transplantation of purified CD34+ cells in the treatment of critical limb ischemia. Journal of Vascular Surgery 2013;58:404-411.e3.
  3. Losordo DW, Kibbe MR, Mendelsohn F, et al., A Randomized, Controlled Pilot Study of Autologous CD34+ Cell Therapy for Critical Limb Ischemia. Circulation: Cardiovascular Interventions 2012;5:821-830.
  4. Kawamoto A, Katayama M, Handa N, et al., Intramuscular Transplantation of G‐CSF‐Mobilized CD34+ Cells in Patients With Critical Limb Ischemia: A Phase I/IIa, Multicenter, Single‐Blinded, Dose‐Escalation Clinical Trial. STEM CELLS 2009;27:2857-2864.
  5. Fang Y, Wei Z, Chen B, et al., A Five-Year Study of the Efficacy of Purified CD34+ Cell Therapy for Angiitis-Induced No-Option Critical Limb Ischemia. STEM CELLS Translational Medicine 2018;7:583-590.