No Clinical Benefit of Intramuscular Delivery of Bone Marrow-derived Mononuclear Cells in Nonreconstructable Peripheral Arterial Disease: Results of a Phase-III Randomized-controlled Trial

Annals of Surgery
Jan H N LindemanJaap F Hamming

Abstract

Prospects for no-option, end-stage peripheral artery disease (PAD) patients remain poor. Although results from open and semiblinded studies fuel hope for cell-based strategies in no-option patients, so far conclusions from the available placebo-controlled studies are not supportive. With the intention to end the remaining controversy with regard to cell therapy for PAD we conducted a confirmatory, double-blinded randomized placebo-controlled phase 3 trial. This randomized controlled trial was registered (NCT00539266). Inclusion criteria included stable or progressive disabling PAD, no imminent need for amputation, absent accepted options for revascularization. Diabetic disease was an exclusion criterion. Bone marrow (500-700 mL) was harvested and bone marrow-derived mononuclear cells were concentrated to 40 mL. Concentrated cells or placebo (diluted blood) were intramuscularly injected at 40 locations of the calf muscle. Fifty-four patients (mean (sd) age 58.2 (14.2) yrs, 58% males) were randomized. Twenty-eight patients received BM-MNCs, 26 placebo. Baseline criteria were similar in the 2 groups. No significant differences were observed for the primary (number of amputations, (pain free) walking distance) and secondary outcome...Continue Reading

References

Mar 3, 1994·The New England Journal of Medicine·C S CleelandK J Pandya
Sep 21, 2002·Lancet·Eriko Tateishi-YuyamaUNKNOWN Therapeutic Angiogenesis using Cell Transplantation (TACT) Study Investigators
Sep 27, 2002·European Journal of Vascular and Endovascular Surgery : the Official Journal of the European Society for Vascular Surgery·W J HofmannH Magometschnigg
May 28, 2005·Arteriosclerosis, Thrombosis, and Vascular Biology·Stephan SchiekoferKenneth Walsh
Jun 23, 2009·Scandinavian Cardiovascular Journal : SCJ·Jussi MäkeläPetri Lehenkari
Aug 8, 2009·Journal of the American College of Cardiology·Justin D AndersonChristopher M Kramer
Sep 17, 2009·The International Journal of Cardiovascular Imaging·Robert B van TongerenJ Hajo van Bockel
Jan 22, 2013·Journal of Vascular Surgery·Irene BargelliniRoberto Cioni
May 15, 2013·Nature Reviews. Cardiology·Brian H Annex
Apr 25, 2015·Circulation Research·John P Cooke, Douglas W Losordo
Feb 26, 2016·Journal of the American Heart Association·Martin TeraaMarianne C Verhaar
Mar 26, 2016·Journal of the American College of Cardiology·Shikhar AgarwalMehdi H Shishehbor
Oct 21, 2016·JAMA Cardiology·Patricia K NguyenJoseph C Wu

❮ Previous
Next ❯

Related Concepts

Related Feeds

Allogenic & Autologous Therapies

Allogenic therapies are generated in large batches from unrelated donor tissues such as bone marrow. In contrast, autologous therapies are manufactures as a single lot from the patient being treated. Here is the latest research on allogenic and autologous therapies.