Experience of Ulcerative Colitis and Crohn’s Disease Patients Treatment with Fetal Stem Cell Suspensions

25 patients with non-specific ulcerative colitis (UC) and 15 patients with Crohn’s disease (CD) underwent treatment with fetal stem cells (FSC). Control group consisted of 19 UC and 11 CD patients. FSC transplantation (FSCT) proved to be effective in both acute and chronic non-specific inflammatory bowel diseases, and at all stages, including advanced.

FSCT efficacy was evaluated by: а) Clinical Findings: Remission %– N of patients in remission/total N of patients ratio; Time until remission – average time span before remission; Term of remission; Life quality improvement – subsidence of the following symptoms: stool frequency and consistency, stool admixtures, fever, abdominal pain intensity. б) Blood count: RBC, Hb.

Remission Criteria: UC: Stool frequency ≤3/day; Absence of blood, mucus in the stool; Absence of abdominal pain, tenesmus, fever, and other systemic problems; No contact hemorrhages, exudates, mucus sponginess and ulceration during rectoromanoscopy. CD: CDAI < 150 (CDAI includes 8 criteria: stool quality, abdominal pain, general well-being, symptoms of external damage of the bowel, antidiarrheal medications intake, abdominal infiltration, hematocrit, body mass)  

UC Patients Clinical Data Reference Group Control Group № % Disease History < 6 months 6 24 5 26 < 1 year 2 8 3 16 1 – 5 years 11 44 32 > 5 years Severity Moderate 15 60 17 89 Severe 10 40 Course Acute 12 1 Continuous chronic 20 Relapsing chronic 68 84 Damage Degree Left-sided 42 Subtotal 4 Total 19 76 53 Activity 14 56 High Surgical History Negative 79 Positive 21 25 100

CD Patients Clinical Data Reference Group Conrol Group № % Disease History < 6 months 1 6 2 18 < 1 year 40 1 – 5 years 5 33 6 – 10 years 13 > 10 years 7 3 27 Localization Caecum - 9 Left-sided Subtotal Total (large bowel) 60 Anastomosis area Prestomal area Rectum stump 20 Anal canal, perianal area Rectum Severity Moderate 8 53 73 Severe 47 Surgical History Negative 45 Positive 55 Total 15 100 11

Each UC patient underwent 1 - 8 transplantations, mean 2,29 ± 0,08. Each CD patient underwent 1 - 3 FSCT, mean 1,93±0,06.

* - R-C differences are statistically valid, р<0,05 Comparative Analysis of the Main Clinical Data of the Reference and Control Groups (UC) R – reference group C – control group Remission: R - 78,26±6,57%* C - 57,89±8,04 % Need for surgery within 1 months after FSCT: R - 12±6,49% C - 21,05±9,35% Average time until remission: R - 21±1,06 days C - 26±1,84 days Remission term: R - 14,3±1,84* months C - 9,451,27 months * - R-C differences are statistically valid, р<0,05

R – reference group C – control group Comparative Analysis of the Main Clinical Data of the Reference and Control Groups (CD) R – reference group C – control group Remission cases: R - 66,67±13,61% C - 62,5±17,12 % R 100% within 7 weeks Average time until remission: R - 4 weeks C - 6 weeks Remission term: R - 28,3±2,67* months C - 12,51,26 months   * - R-C differences are statistically valid, р<0,05

UC Patients Life Quality

CD Patients Life Quality

Post-FSCT Defecation Frequency in UC (1 month)

CDAI Dynamics in CD Patients

Pre- and Post-FSCT RBC Count in UC Reference and Control Groups (х10^12/l)

Pre- and Post-FSCT Hb Level in UC Reference and Control Groups (g/l)

Pre- and Post-FSCT RBC Count in CD Reference and Control Groups (х10^12/l)

Pre- and Post-FSCT Hb Level in CD Reference and Control Groups (g/l)

Indications for FSCT in UC and CD Progressive disease, non-responsive to routine therapy after 2 weeks; Extraintestinal complications; Impossibility of surgery due to grave condition caused by anemia, hypoproteinemia, advanced metabolic disorders; Cachexy; Difficulties in finding compatible blood type for transfusion, or donor blood-recipient incompatibility confirmed by the test.  

FSCT Contraindications Vasculitis exacerbation: capillaritis, phlebitis, arteritis – FSCT is possible after remission, but no earlier than after 3 months; Acute thrombosis: FSCT is possible no earlier than after 3-6 months; Acute ophthalmic hemorrhages: FSCT is possible no earlier than after 3 months; Advanced pulmonary hypertension secondary to vasculitis, thrombosis, pneumonia, accompanied by development of acute or subacute pulmonary heart ; Terminal stage of the disease (expressed intoxication, advanced metabolic dysfunctions and decompensation of internal organs).

Results of FSC Suspensions Application in Combined UC and CD Treatment Inflammation subsidence Shorter time until remission and longer remission Life quality improvement Possibility to postpone or avoid surgery Possibility to reduce the dose of glucocorticoids or discontinue them without interrupting remission Quick and effective RBC count restoration Co-morbidity prevention