Experience of Ulcerative Colitis and Crohns Disease Patients Treatment with Fetal Stem Cell Suspensions

25 patients with non-specific ulcerative colitis (UC) and 15 patients with Crohns 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 < 1 year – 5 years > 5 years SeverityModerate Severe CourseAcute31215 Continuous chronic Relapsing chronic Damage DegreeLeft-sided Subtotal1415 Total ActivityModerate High Surgical HistoryNegative Positive Total

CD Patients Clinical Data Reference Group Conrol Group % % Disease History< 6 months16218 < 1 year – 5 years – 10 years > 10 years17327 LocalizationCaecum--19 Left-sided17218 Subtotal--218 Total (large bowel) Anastomosis area--19 Prestomal area17-- Rectum stump320-- Anal canal, perianal area17-- Rectum--327 SeverityModerate Severe Surgical HistoryNegative Positive Total

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

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

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

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