Adjunct treatment of multidrug resistant (MDR) or extreme drug resistant (XDR) Tuberculosis (TB) with autologous mesenchymal stem cells.

Phase 1

Recruiting

Conditions: multi-drug resistant (MDR) tuberculosis extreme drug resistant (XDR)tuberculosis
A15-A19
U82.1
Tuberculosis
Resistance to methicillin

Registration Number: DRKS00000763

Lead Sponsor: Republican Research and Practical Center for Pulmonology and Tuberculosis (RRPCPT), Minsk Belarus

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

MDR or XDR without response to therapy, chronic disease or at least a single treatment failure

Patients for enrolment must satisfy all the criteria below:
1.HIV-ve
2.Hepatitis -B and -C negative patient
3.MDR- or XDR- TB confirmed by drug susceptibility testing (DST) at the time of the bone marrow harvest for MSC generation
4.Patient who show clinical signs of worsening despite receiving second line TB treatment
5.M.tuberculosis (Mtb) detected by culture with available drug susceptibility results for current isolate
6.Age: at least 21 years

Exclusion Criteria

Pregnancy, tumor disease, HIV+, Hepatitis C+, active Hepatitis B, Blood koagulation problems, active infections other than tuberculosis.

Any one of the criteria below make the patient ineligible for enrolment into the study
1.HIV positivity
2.Hepatitis B or C positivity
3.First line drug treatment susceptible Mtb strain
4.Autoimmune diseases
5.Pregnancy
6.Multi-organ failure
7.Sepsis (any bacterial sepsis)
8.Abscess formation other than Mtb
9.Cancer
10.Anti-DNA antibodies
11.Allergies
12.Clinical significant hypertonus
13.Younger than 21 years and older than 65 years.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety, i.e. no clinical worsening of the disease, no sputum conversion (if the patient was AFS - , all patients are culture pos upon study entry), any worsening concerning vital parameters, and routine blood work.

Secondary Outcome Measures

Name	Time	Method
Detection of immmunological surrogate markers as a result of MSC infusion <br><br>Detection of biologically relevant M.tub immune responses <br><br>Changes detected by Xray<br><br>Culture conversion (from culture positive to culture negative).