multi-drug resistant (MDR) tuberculosis extreme drug resistant (XDR)tuberculosis A15-A19 U82.1
Conditions
Interventions
Group 1: After optimal M/XDR-TB chemotherapy initiation, a bone marrow aspirate (20-80 ml) will be performed under standard conditions and local anesthesia, autologous MSCs will be selected and cultur
cell surface expression of markers will be analyzed by flow cytometry. Optimal dose of MSCs (about 1 million cells) / kg bodyweight will be infused i.v.
Chemotherapy:
The enrolled patients are treat
this includes proficiency testing concerning M.tb identification and DST.
After chemotherapy initiation patients are monitored routinely in accordance with national M/XDR-TB guidelines.
Patients’ moni
conversion from smear negative to smear positive
conversion from culture negative to culture positive
worsening in chest X-ray
any alteration of blood tests, defined by reference values of the lab methods used at the RRPCPTB (Minsk)
any event worsening health status of the patients.
Sputum conversion monitoring:
Sputum (induced sputum) patient should give at start of chemotherapy and on a regular base every month.
Radiology moni
Sponsors
Republican Research and Practical Center for Pulmonology and Tuberculosis (RRPCPT), Minsk Belarus
Karolinska Institutet
Eligibility
Sex/Gender
All
Age
21 Years to 70 Years
Inclusion criteria
Inclusion criteria: MDR or XDR without response to therapy, chronic disease or at least a single treatment failure Inclusion criteria: 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
Exclusion criteria: Pregnancy, tumor disease, HIV+, Hepatitis C+, active Hepatitis B, Blood koagulation problems, active infections other than tuberculosis. Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Detection of immmunological surrogate markers as a result of MSC infusion Detection of biologically relevant M.tub immune responses Changes detected by Xray Culture conversion (from culture positive to culture negative). | — |
Countries
Belarus
Contacts
Public ContactMarkus Maeurer
MTC, LabMed and CAST, Karolinska Institutet and Hospital
Outcome results
None listed