Tag Archives: mesenchymal stromal cells

Fecal Calprotectin Monitoring Helpful at Identifying Relapse in IBD

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Thanks to Ben Gold for this reference: Y. Zhulina et al. Aliment Pharm Ther 2016; 44: 495-504.

Methods: 

  • Patients aged 18 years or older, with a known diagnosis of IBD in clinical remission, were prospectively studied. Patients provided faecal samples every third month and were prospectively followed until the first clinical relapse or the end of the 2-year follow-up period.  
  • Relapse was defined as increasing symptoms necessitating intensified medical therapy or surgery.

Key finding:

  • Among 104 patients, Crohn’s disease (n = 49) and ulcerative colitis (n = 55), 37 had a relapse. A doubling of faecal calprotectin level between two consecutively collected samples was associated with a 101% increased risk of relapse (HR: 2.01; 95% CI: 1.53–2.65; P < 0.001).

My take: Another study showing that stool calprotectin is quite useful. How long will it be until I will not need to write letters to insurance companies to get this test covered?

Also noted in the same issue: 
“The safety of autologous and metabolically fit bone marrow mesenchymal stromal cells in medically refractory Crohn’s disease – a phase 1 trial with three doses” (pages 471–481) T. Dhere, I. Copland, M. Garcia, K. Y. Chiang, R. Chinnadurai, M. Prasad, J. Galipeau and S. Kugathasan. Aliment Pharm Ther 2016; 44: 471-81. This study examined the use of mesenchymal stromal cells in 12 patients.

In conclusion, a single infusion of fresh autologous bone marrow-derived mesenchymal stromal cells propagated ex vivo using a non xenogeneic human platelet lysate growth supplement at doses ranging 2–10 million cell/kg BW was well tolerated in patients with medically refractory moderate to severe Crohn’s disease in this preliminary study. Our data neither addressed long-term safety nor sustained efficacy. However, this study informs that a future phase 2 study 

A previous study of mesenchymal stromal cells was briefly discussed in a previous blog: Sanjay Gupta is Wrong…about Stem Cell Therapy

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Hidden Lake at Glacier National Park

Sanjay Gupta is Wrong… about Stem Cell Therapy

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According to a 3 min video (and article) publicized on twitter by Dr. Sanjay Gupta, Stem Cell therapy for Crohn disease is 97% effective. ow.ly/smrJM I sent him a tweet asking for data to support this figure but have not heard back.  That being said, there are very few treatments that work in 97% of patients with any chronic disease.

The context of the video regards a model who has had 75 hospitalizations for Crohn disease and is unable to tolerate standard treatment.  “Thus far, there is a 97 percent success rate with this procedure, but it’s not fully covered by insurance, so Jocelyn must find the money for the procedure, her travel, and the long recovery.”

To my knowledge, stem cell therapy, while promising, for Crohn disease remains an experimental treatment without any large studies proving its effectiveness. 

An abstract at DDW last year (Stem Cell Transplantation Halts Crohn’s Disease – Medscape) reported that among the 22 patients in the stem cell treatment group (who were refractory to multiple other medications), 40% had mucosal healing and 58% had segmental healing. The presenting physician, Dr. Christopher Hawkey, noted ‘there were serious adverse events and many patients were not cured…. We need controlled trials showing a long-term risk/benefit ratio.’

Another study (Blood. 2010;116:6123-6132) with 24 patients, reported that “the percentage of clinical relapse-free survival defined as the percent free of restarting CD medical therapy after transplantation is 91% at 1 year, 63% at 2 years, 57% at 3 years, 39% at 4 years, and 19% at 5 years.”

Bottomline: I think the information in the video is not accurate.  Inevitably, it will lead to a lot of ill-informed questions by families.  When a respected physician posts this type of unsupported information, it has the potential to undermine not just his credibility but other physicians as well. Perhaps, Dr. Gupta will consider revising this information.

Related article:

Clin Gastroenterol Hepatol 2014; 12: 64-71: “A phase 2 study of allogeneic mesenchymal stromal cells for luminal Crohn’s disease refractory to biologic therapy.” Results: among the 15 patients (of 16) who completed the study, the mean CDAI score was reduced from 370 to 203.  Twelve patients had a clinical response and eight had clinical remission.  All patients received 4 weekly infusions of mesenchymal stromal cells.  One patient had a stage 1 adenocarcinoma (colon) but the authors think that this was likely present prior to the infusions. Why this study is important? If shown effective in larger studies, mesenchymal stromal cells  are much safer than allogeneic stem cells as donor to recipient matching is not needed nor chemotherapeutic marrow conditioning.