Inflammatory bowel disease (IBD) is an immune-mediated disease.
It involves a complex interplay of a patient’s genetics and environmental influences that result in an inappropriate response of the patient’s immune system to intestinal microbes . IBD usually includes Crohn’s disease (CD) and ulcerative colitis (UC). These are relapsing and remitting conditions characterized by chronic inflammation at various sites of the gastrointestinal (GI) tract which often lead to diarrhoea and abdominal pain .
Ulcerative colitis (UC) is a chronic, idiopathic inflammatory disease that affects the colon, most commonly afflicting adults aged 30–40 years and resulting in disability. It is characterised by relapsing and remitting mucosal inflammation, starting in the rectum and extending to proximal segments of the colon .
Crohn’s disease (CD) is a complex chronic inflammatory gastrointestinal condition with variable age of onset, disease location and behaviour . Mucosal biopsies show focal or patchy inflammation and/or crypt distortion along with discontinuous segments of disease (‘skip lesions’), ileal involvement and granulomatous inflammation. There is a tendency for inflammation to be worse in the proximal colon .
In 5 to 15% of IBD patients, endoscopic and histological assessments cannot distinguish between CD and UC. These patients are labelled as IBD-unclassified (IBD-U). If features are still indeterminate after colectomy histology is assessed, the condition is called indeterminate colitis [6,7,8].
How Our Products Can Treat Inflammatory Bowel Disease
We use products derived from the umbilical cord tissues of human babies in all our therapy programs - Wharton's Jelly MSCs (wjMSCs). In both animal and human studies, MSCs of differing sources have been found to be able to:
Treating Inflammatory Bowel Disease
In 2011, researchers from the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing treated 4 CD patients with Wharton’s Jelly MSCs (wjMSCs) extracted from umbilical cords obtained from local maternity hospitals and 3 UC patients with bone marrow MSCs (bmMSCs) aspirated from a healthy relative of each patient. The isolated MSCs were given by intravenous infusions at a dose of 1 million MSCs per kilogram of body weight. After treatment, all patients continued with their existing treatments of steroids and/or immunosuppressants. Diarrhoea frequency and abdominal pain/cramps gradually improved in all 7 patients, accompanied by a significant reduction in CDAI scores in CD patients and CAI scores in UC patients. At the 3-month visit, 5 patients achieved remission. Maintenance of remission lasted for more than 24 months in 2 patients while 2 other patients had relapsed at 6 and 7 months, respectively. A significant reduction in fistula size and drainage was found in 1 patient. 2 CD patients reported a 14.9-point reduction in EIS scores at 4 months post-treatment. 1 UC patient reported a 2-point decrease in EAI at 5 months post-transplantation. Rough mucosa, polypoid lesions ulcers as well as the extent of the inflamed area and the dense lymphocytic infiltration in the mucosa propria were found to have significantly decreased .
Between 1998 to 2012, a total of 56 CD patients have been treated across 8 different clinical studies with high-dose chemotherapy and subsequent reinfusion of the patient’s own (autologous) bone marrow MSCs (bmMSCs). Each study chose to evaluate different clinical indices. A summary shows that 28 out of 35 patients (80%) entered remission, with no relapses, by the end of the evaluation period (3 months to 7 years). 9 out of 13 patients (69%) maintained long-term remission, with relapses, by the end of the evaluation period (15 months to 10 years). 15 out of 18 patients (83%) were able to discontinue the use of corticosteroid and remained steroid-free at the end of the evaluation period (5 years). 11 out of 18 patients (61%) were able to discontinue the use of medications and remained medication-free at the end of the evaluation period (5 years). 36 out of 36 patients (100%) were found to have clinical/endoscopic improvements within 3 to 6 months post-treatment while 4 out of 4 patients (100%) experienced fistula closure within 3 months post-treatment [12,13,14,15,16,17,18,24].
In 2020, researchers from the Leiden University Medical Center, the Netherlands published a 4-year clinical evaluation of different doses of donor (allogeneic) bmMSC treatment for perianal CD fistulas in 15 patients. The patients were divided into 3 groups of 5 patients each.
4 years after bmMSC therapy, all fistulas were closed in 4 patients from Group 2, 63% of fistulas were closed in 4 patients from Group 1 and 43% of fistulas were closed in 4 patients from Group 3. Anti-HLA antibodies were not detected in any of the patients at 24 weeks or 4 years after therapy indicating that treatment was well tolerated with no adverse reactions or immune rejections. Pelvic MRIs showed significantly smaller fistula tracts after 4 years .
Similar studies using either the patient’s own (autologous) or donor (allogeneic) adipose-derived MSCs (adMSCs) have reported complete fistula closures in 88 out of 126 patients (70%) within 8 weeks post-treatment and lasting as long as 30 months (end of study evaluation period). Incomplete closure, with decreased output flow, was reported in 3 out of 3 patients lasting as long as 30 months (end of study evaluation period). 16 out of 24 patients (67%) had a reduction in the number of draining fistulas within 6 months post-treatment. 32% (8 out of 25 patients) had complete closure of all existing fistula tracts 6 months post-treatment while only 16% (4 out of 24 patients) experienced recurrence of fistulas within 8 weeks to 12 months post-treatment [21,22,23,25,26,27,28].
In 2013, researchers from the Mount Sinai School of Medicine, New York gathered 12 patients with moderate-to-severe CD who were unresponsive to previous therapy. All patients were given 2 intravenous infusions of placenta-derived MSCs (pMSCs) 1-week apart and monitored weekly for 5 weeks and assessed at 6 months, 1 year, and 2 years after infusion. 6 subjects received 2 infusions of 200 million pMSCs (low-dose group) and 6 subjects received 2 infusions of 800 million pMSCs (high-dose group). All subjects in the low-dose group achieved a CDAI score decrease of ≥70 points and 3 achieved remission. 2 subjects in the high-dose group achieved response but none met the remission criteria of CDAI decrease of ≥100 to <150 points .
In 2010, Russian researchers intravenously administered 150 to 200 million donor bmMSCs each to 50 patients; 39 UC patients and 11 CD patients. A statistically significant decrease in the indices of clinical and morphological activities as well as the inflammatory process was noted in all patients. The treatment made it possible to reduce or discontinue corticosteroids in 34 of the 50 patients with the hormone-dependent and hormone-resistant forms of UC and CD .
That same year, the same group intravenously administered 150 to 200 million donor bmMSCs each to 44 UC patients. 34 patients experienced a statistically significant reduction in clinical and morphological indices of inflammatory activity. Treatment enabled most patients with hormone-dependent and steroid resistance forms of UC to discontinue the use of corticosteroids as well as for 7 patients to reduce their dosage .
Achieving high standards in our work is of paramount importance to us. Depending on a patient’s needs, we combine our premium grade Passage 2 wjMSCs with physiotherapy, occupational therapy, speech and language therapy and/or rehabilitative medicine.
Why Choose Cyrona?
All our therapy packages come inclusive of:
How Do We Proceed
All our therapies are charged based on the number of wjMSCs and supplementary infusions required for the patient’s specific condition. As no two people are alike, our specialists review each patient’s medical reports before tailoring a therapy catered to addressing his or her individual needs.
You may chat with one of our Customer Care Representatives or send an e-mail detailing the patient’s condition to one of our Liaison Officers. It would expedite the process if you can provide us with:
Upon getting in touch with us, a Liaison Officer evaluates and assigns the case to the specialist best equipped to treat the condition. A therapy, unique only to the patient, is drawn up and a price quoted accordingly.
Should you decide to proceed with therapy, our specialists require that all patients have Cancer Marker Screening performed in their country of residence before travelling to us for therapy. If the patient has had Cancer Marker Screening within the last 3 months, you may e-mail those results to us. In the event that the patient’s Cancer Marker Screening results are not satisfactory, our specialists will refuse to proceed with therapy. It is for this reason that we request that patients have Cancer Marker Screening performed in their country of residence prior to travelling to us.
One week prior to arrival, a deposit payment is required in order to arrange accommodation and transportation.
Full payment is required to be made one-day prior to therapy commencement.
Post-treatment, our specialist will provide the patient with a post-treatment protocol as well as what to expect on his or her journey towards a better, and hopefully, healthier new life.
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