Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease: A Randomized Controlled Clinical Trial

Abstract

Background/AimsStem cell therapy has been applied to treat a variety of autoimmune diseases, including Crohn’s disease (CD), but few studies have examined the use of umbilical cord mesenchymal stem cells (UC-MSCs). This trial sought to investigate the efficacy and safety of UC-MSCs for the treatment of CD.MethodsEighty-two patients who had been diagnosed with CD and had received steroid maintenance therapy for more than 6 months were included in this study. Forty-one patients were randomly selected to receive a total of four peripheral intravenous infusions of 1×106 UC-MSCs/kg, with one infusion per week. Patients were followed up for 12 months. The Crohn’s disease activity index (CDAI), Harvey-Bradshaw index (HBI), and corticosteroid dosage were assessed.ResultsTwelve months after treatment, the CDAI, HBI, and corticosteroid dosage had decreased by 62.5±23.2, 3.4±1.2, and 4.2±0.84 mg/day, respectively, in the UC-MSC group and by 23.6±12.4, 1.2±0.58, and 1.2±0.35 mg/day, respectively, in the control group (p<0.01, p<0.05, and p<0.05 for UC-MSC vs control, respectively). Four patients developed a fever after cell infusion. No serious adverse events were observed.ConclusionsUC-MSCs were effective in the treatment of CD and produced mild side effects.

Cell therapy with intravascular administration of mesenchymal stromal cells continues to appear safe: An updated systematic review and meta-analysis

“…Patient populations were diverse and included cardiovascular (12 trials, n = 612 patients) [21,24À27,29,37,40,42,44,49,58], neurological (10 trials, n = 242 patients) [30À32, 36,45,48,57,62,65,69], renal (three trials, n = 177 patients) [55,63,67], liver (seven trials, n = 404 patients) [35,43,47,53,54,59,66], respiratory (three trials, n = 134 patients) [18,23,68] and endocrine diseases (four trials, n = 169 patients) [22,28,39,50], hematological/oncological malignancies (five trials, n = 318 patients) [33,34,41,46,71], immune deficient or inflammatory conditions (nine trials, n = 544 patients) [20,38,51,52,60,61,64,70,72], general frailty (one trial, n = 30 patients) [56], and severe sepsis in severely neutropenic patients with hematologic malignancies (one trial, n = 30 patients) [19].…”

“…With respect to MSC preparation and administration, of the 55 included RCTs, 31 (56¢4%) examined bone marrow [19,21-27,29-34,36,39,41-43,45,47,53,55À59,61,66,68,71], 16 (29¢1%) umbilical cord [28,35,38,40,44,46,[48][49][50][51][52]54,60,63,65,72], four (7¢3%) adipose-derived MSCs [18,20,62,64], two (3¢6%) placenta-derived cells [69,70]; and in two RCT (3¢6%) the source of MSCs was unclear [37,67]. See Supplementary Table 1 [33,34,41,67].…”

Human Placenta-Derived Mesenchymal Stromal Cells: A Review from Basic Research to Clinical Applications

“…Likewise, in a randomized controlled clinical trial, intravenous injection of PMSC patient condition improved significantly allowing a significant reduction in steroid dosage. Additionally, several patients with anal fistula showed remarkable improvement [108].…”

Tissue engineering strategies combining molecular targets against inflammation and fibrosis, and umbilical cord blood stem cells to improve hampered muscle and skin regeneration following cleft repair

“…In patients with Crohn's Disease, the intravenous infusion of allogeneic hUCMSCs improved disease conditions with only mild side effects like fever and respiratory tract infection. 152 In atopic dermatitis, a chronic and relapsing skin disease involving pruritus, xerosis, and eczematous lesions, infusion of hUCMSCS was effective without side effects. 150 Moreover, also allogeneic hUCMSCs have been successfully used in multiple sclerosis patients improving the patients' symptoms without serious adverse effects.…”

“…[154][155][156][157] while no immunogenic rejection was observed after allogeneic transplantation. 152,153 The low immunogenicity of hUCMSCs would also allow the use of hUCMSCs from a central cord blood stem cell bank when autologous stem cells are not available.…”