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

2. 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.

3. 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.

4. 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)

5. 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

6. 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

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

8. * - 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

9. 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

10. UC Patients Life Quality

11. CD Patients Life Quality

12. Post-FSCT Defecation Frequency in UC (1 month)

13. CDAI Dynamics in CD Patients

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

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

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

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

18. 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.

19. 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).

20. 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