The short answer. “Stem cell therapy” for inflammatory bowel disease means three different things. Injecting MSCs into perianal fistulas looked promising and was approved in Europe, but a larger confirmatory trial showed no benefit over placebo and the product was withdrawn in 2024. HSCT, which uses chemotherapy, did not achieve sustained remission in its main trial and caused serious infections. MSC drips have small, mostly low-quality studies with encouraging signals, particularly in ulcerative colitis. The evidence for all three is still developing.

Stem cell and exosome treatment for Crohn’s disease and ulcerative colitis is offered as an adjunct: alongside established gastroenterology care, a healthy lifestyle and, where appropriate, your main treatment protocol, never instead of them. The clinical evidence for IBD is still developing, and I will tell you exactly what it does and does not show.

Why patients with IBD ask about stem cells

Crohn’s disease and ulcerative colitis are lifelong immune-driven conditions of the gut. Modern biologic and targeted drugs control them well for many patients, but some do not respond, lose their response, or develop complications such as fistulas, abnormal channels between the bowel and the skin around the anus. Those patients understandably look for something more.

Three different treatments share the same name

The fistula story: why one positive trial is not enough

In 2016, a trial of 212 patients with complex perianal fistulas found that a single injection of donor fat-derived MSCs achieved combined remission, meaning the fistulas had closed and MRI showed no abscess, in 50% of patients at 24 weeks, compared with 34% given a placebo injection.¹ On the strength of that result, the product (darvadstrocel, sold as Alofisel) was approved in Europe in 2018.

A larger confirmatory trial of 568 patients then found almost no difference: 48.8% remission with the cells against 46.3% with placebo. None of its secondary goals were met either, and in December 2024 the product was withdrawn from the EU market.² No new safety concerns were found. The treatment simply did not work better than the careful surgical care that both groups received.

I tell this story to patients because it shows exactly why a single encouraging study, however well run, is not the same as proof.

What about HSCT for Crohn’s disease?

In the main randomised trial, 45 adults with Crohn’s disease that had not responded to other treatments were assigned either to HSCT straight away or a year later. After a year, sustained remission was achieved in 2 of 23 transplanted patients and 1 of 22 controls, which is not a meaningful difference. Infections were far more common after transplant, and one patient died.³ HSCT is not a routine option for Crohn’s disease.

Can MSC drips help Crohn’s or ulcerative colitis?

A 2015 review of stem cell therapy in IBD, excluding chemotherapy-based treatments, concluded that the results suggest a promising role, but that cost and incomplete understanding of the effect limit its use in clinical practice.⁴

For ulcerative colitis, a 2019 review of 7 human trials with 216 patients found high rates of improvement with MSCs, and no serious adverse events were reported. But the authors rated the quality of the trials as poor: most had no control group, only one was randomised, and none used colonoscopy or biopsy to confirm healing.⁵

So the honest summary is that MSC drips for IBD look safe in the studies so far and show encouraging signals, but they have not been proven in good-quality randomised trials.

Before any stem cell treatment: the whole picture

With Crohn’s disease or ulcerative colitis, as with any autoimmune condition, I do not move straight to stem cells. Before anything is planned, I look at the whole picture:

• Your current main treatment: what you take, how well it is working, and whether it has been optimised.
• A second or third opinion where it would help. Sometimes the most useful thing I can do is refer you back to a gastroenterologist to review your main treatment plan.
• Other conditions that can contribute to autoimmune activity, such as other autoimmune diseases, thyroid problems, low vitamin D or ongoing infections.
• Your lifestyle: how stressful your life is, your sleep, diet, activity and smoking.

Regenerative treatment, if it is appropriate at all, is one part of that plan, not the whole of it.

Stem cells or exosomes?

Exosomes are a cell-free option for patients who prefer not to receive living cells; MSCs are a cell-based option. In my clinical experience, some patients report earlier changes following exosome treatment, whereas responses following MSC treatment may develop more gradually. No comparative trial in IBD has shown this. It is clinical observation, not trial evidence.

Should I stop my IBD medication?

No. Continue your biologic, immunosuppressant or other treatment exactly as prescribed. Stopping IBD treatment can trigger a severe flare. Any change is made by your gastroenterologist. I am happy to write to them so your care is coordinated.

How would we know whether it helped?

We record a baseline and repeat the same measures at about three and six months:

• Symptoms, using a standard activity score, recorded the same way each time.
• Blood and stool markers: CRP and faecal calprotectin.
• Steroid use and medication changes.
• Colonoscopy or MRI, at the intervals your gastroenterologist already uses.

Is it safe?

Across 55 randomised trials and 2,696 patients in other conditions, the only side effect clearly linked to MSC drips was a short-lived fever. The pooled analysis did not detect an increased rate of infection, thrombotic events or malignancy during the available follow-up.⁶ That does not exclude rare or long-term risks.

At our clinic, cells and exosomes are prepared by two established, regulated laboratories: one Italian, operating since 2009 and in Dubai since 2013, and one British, in Dubai since 2017. Every patient is screened and assessed before treatment.

Who should not have it

• Anyone with active cancer or a recent cancer history.
• Pregnancy, or actively trying to conceive.
• Active infection, including an abscess.
• A severe flare or complication that needs hospital care; that is treated first.

Frequently asked questions

Is there an approved stem cell treatment for Crohn’s disease?

The one product approved in Europe, for perianal fistulas, was withdrawn in 2024 after a larger trial showed no benefit over placebo.²

Can stem cells cure Crohn’s or ulcerative colitis?

No. They are being studied for their potential to calm gut inflammation, but they are not a cure.

Can MSCs heal my fistula?

The first trial was encouraging,¹ but the larger trial found no benefit over placebo.² Fistulas need your colorectal surgeon and gastroenterologist.

Is the evidence better for ulcerative colitis?

The signals are encouraging, but the trials are small and mostly of poor quality.⁵

Can I stop my biologic if stem cells work?

No. Any change to your medication is made by your gastroenterologist, based on objective markers, not on how you feel after treatment.

This article is patient education and does not replace the advice of your gastroenterologist.

References

1. Panés J, García-Olmo D, Van Assche G, et al. Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn’s disease: a phase 3 randomised, double-blind controlled trial. Lancet. 2016;388(10051):1281–1290. doi:10.1016/S0140-6736(16)31203-X
2. European Medicines Agency. Alofisel withdrawn from the EU market. 13 December 2024. ema.europa.eu
3. Hawkey CJ, et al. Autologous hematopoetic stem cell transplantation for refractory Crohn disease: a randomized clinical trial. JAMA. 2015;314(23):2524–2534. doi:10.1001/jama.2015.16700
4. Dave M, Mehta K, Luther J, Baruah A, Dietz AB, Faubion WA Jr. Mesenchymal stem cell therapy for inflammatory bowel disease: a systematic review and meta-analysis. Inflamm Bowel Dis. 2015;21(11):2696–2707. doi:10.1097/MIB.0000000000000543
5. Shi X, Chen Q, Wang F. Mesenchymal stem cells for the treatment of ulcerative colitis: a systematic review and meta-analysis of experimental and clinical studies. Stem Cell Res Ther. 2019;10:266. doi:10.1186/s13287-019-1336-4
6. Thompson M, et al. Cell therapy with intravascular administration of mesenchymal stromal cells continues to appear safe: an updated systematic review and meta-analysis. EClinicalMedicine. 2020;19:100249. doi:10.1016/j.eclinm.2019.100249