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IRCT20100212003331N2 IRCT 2022-01-19 Shiraz University of Medical Sciences The survey of efficacy of intracoronary autologous bone marrow-derived mononuclear stem cell injection in treatment of children with dilated cardiomyopathy The survey of efficacy of intracoronary autologous bone marrow-derived mononuclear stem cell injection in treatment of children with dilated cardiomyopathy (The third phase of clinical trial) 2022-01-08 anticipated 10 Recruiting https://irct.ir/trial/61088 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 3 Cardiomyopathy. Patients choose from all cases of dilated cardiomyopathy without cause or due to myocarditis who have not responded well to the usual routine antifailure treatments and have frequent hospitalizations or dependence on injectable cardiac inotropic drugs in their last hospitalization for more than 2 weeks. And if the study conditions are accepted and the possible complications of angiography and this treatment are announced, they will be included in the list of patients. For 5 years, all patients who meet the entry requirements will enter the plan and their information will be collected. Approximately every year, about 10 patients with the specified conditions are referred to Shiraz hospitals. Patients with eligibility will be admitted to the pediatric cardiology department and two-dimensional echo and color Doppler, Tissue Doppler and Speckle Tracking Echocardiography will be recorded before the patient is injected and the patient will be examined for coagulation, liver, kidney and clot tests. If possible, a 6-minute walk test will also be performed. In the morning, a bone marrow aspiration sample will be taken in the morning in collaboration with the Pediatric Hematology Fellowship. According to the protocol provided by the Stem Cell Center of Shiraz University of Medical Sciences, the sample will be transferred to the mother and child hospital in a suitable culture medium for isolation of stem cells in the clean room of this hospital (Clean Room). In this center, the process of preparation and isolation of cells under aseptic conditions will be performed by the colleagues of the Stem Cell Institute, and the solution for injection in a volume of 10 cc and containing at least 20 million stem cells will be returned to the hospital of origin with cold chain (this process It takes about 4 hours and the cells are injected on angiography on the same day, and a panel of different antibodies is placed to identify the cell surface markers.Checking the specifications and identifying the prototype (bone marrow):All bone marrow cells are immature, multivalent cells that originate from a common common ancestral cell. These cells are precursors to various classes of hematopoietic cells as well as non-hematopoietic stem cells, including endothelial progenitor cells and mesenchymal stem cells in small numbers. Naturally, these cells lack the specific markers of differentiated cells. In order to check the characteristics and identify the prototype (bone marrow), panels of different antibodies were placed, which are briefly mentioned. The results of the analysis were checked by BD FACS Calibur flow cytometer and read using CellQuest Pro software.(Complete results with specifications and identification analysis are also available if required).Panel 1: Marker of immature T lymphocyte cell lineCD3: 11.4%CD13: 3.72%Panel 2: Marker of immature B lymphocyte cell lineCD10: 1.00%CD20: 5.22%CD45: 30.8%Panel No. 3: Multivalent Stem Cell MarkerCD34: 0.317%CD117: 0.272%CD45: 55.2%Specification and identification of the final cell product:Since all cells in the bone marrow, including mononuclear cells, are responsible for producing lymphoid blood cell lines and monocytes, as well as non-hematopoietic stem cells, including mesenchymal stem cells, They are immature, polyvalent cells that originate from a common common ancestral cell. Therefore, they do not have specific markers of differentiated blood cells.To evaluate the characteristics and identify the cellular product, panels of different antibodies were placed, which are briefly mentioned. (Complete results with specifications and identification analysis are also available if required).Panel 1: Marker of immature T lymphocyte cell lineCD3: 62.0%CD13: 18.0%Panel 2: Marker of immature B lymphocyte cell lineCD10: 2.82%CD20: 8.59%CD45: 77.70%Panel No. 3: Multivalent Stem Cell MarkerCD34: 0.754%CD117: 0.709%CD45: 82.9%Selective coronary angiogram is performed and after determining the path of coronary arteries by an over the wire balloon, the initial part of each of the three main coronaries LAD, LCX and RCA is temporarily tight for less than 2 to 3 minutes based on ECG changes. (To reduce the speed of coronary blood flow and increase the residence time of the solution containing cells in the coronary tract) and 3 cc of the prepared solution is injected at low speed.All patients will be monitored for ECG changes and cardiac enzymes for up to 24 hours during and after the procedure. Hospitalization of patients continues until a completely stable clinical condition develops.Subsequent follow-ups of patients will be based on ECG, 2D echo and color Doppler + Tissue Doppler and Speckle tracking echo at intervals of 3 months, 6 months and 12 months. Follow-up results and patients' performance class will be recorded on Form One.At the end of one year of follow-up, patients will be statistically evaluated. Yes - There is a plan to make this available What will be shared: Exel When: 3 years To whom: For university researches Conditions: request of researchers Where to obtain: Hamid Amoozgar How to obtain: request form Comments:
public Hamid Amoozgar
Zand BLV
Shiraz Iran (Islamic Republic of) 1331171936 +98 71 3647 4298 amozgah@sums.ac.ir Shiraz University of Medical Sciences scientific Hamid Amoozgar
Zand BLV
Shiraz Iran (Islamic Republic of) 1331171936 +98 71 3647 4298 amozgah@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Age between 1 to 18 years - Definitive diagnosis of dilated cardiomyopathy without a treatable cause (arrhythmia - ALCAPA - tumors, etc.) Lack of response to maximum oral antifailure treatments and the need for frequent hospitalization or dependence on injectable inotropes4 Lack of response to maximum oral antifailure treatments and the need for frequent hospitalization or dependence on injectable inotropes4- Normal kidney function and no serious functional liver damage (INR> 2 - Alb <3 - AST, ALT more than 3 times of Nl Range). - no hematological disorders No syndromic diseases Accepting the participation form in the study and being aware of the side effects of this treatment - If the initial response is appropriate, increase the EF by 5% in the first injection of the second injection, 3 months after the first injection. 1 year 18 years Both Non-compliance with any of the entry conditions at each stage of the study before stem cell injection Not accepting the informed consent form to participate in the study or performing cardiac angiography. Appropriate response to oral antifailure treatment Active infection Less than 6 months have passed since the diagnosis of dilated cardiomyopathy Existence of refractory arrhythmia due to dilated cardiomyopathy Existence of bleeding and serious coagulation disorder I42.0 Dilated cardiomyopathy Treatment - Other Patients choose from all cases of dilated cardiomyopathy without cause or due to myocarditis who have not responded well to the usual routine antifailure treatments and have frequent hospitalizations or dependence on injectable cardiac inotropic drugs in their last hospitalization for more than 2 weeks. And if the study conditions are accepted and the possible complications of angiography and this treatment are announced, they will be included in the list of patients. For 5 years, all patients who meet the entry requirements will enter the plan and their information will be collected. Approximately every year, about 10 patients with the specified conditions are referred to Shiraz hospitals. Patients with eligibility will be admitted to the pediatric cardiology department and two-dimensional echo and color Doppler, Tissue Doppler and Speckle Tracking Echocardiography will be recorded before the patient is injected and the patient will be examined for coagulation, liver, kidney and clot tests. If possible, a 6-minute walk test will also be performed. In the morning, a bone marrow aspiration sample will be taken in the morning in collaboration with the Pediatric Hematology Fellowship. According to the protocol provided by the Stem Cell Center of Shiraz University of Medical Sciences, the sample will be transferred to the mother and child hospital in a suitable culture medium for isolation of stem cells in the clean room of this hospital (Clean Room). In this center, the process of preparation and isolation of cells under aseptic conditions will be performed by the colleagues of the Stem Cell Institute, and the solution for injection in a volume of 10 cc and containing at least 20 million stem cells will be returned to the hospital of origin with cold chain (this process It takes about 4 hours and the cells are injected on angiography on the same day, and a panel of different antibodies is placed to identify the cell surface markers.Checking the specifications and identifying the prototype (bone marrow):All bone marrow cells are immature, multivalent cells that originate from a common common ancestral cell. These cells are precursors to various classes of hematopoietic cells as well as non-hematopoietic stem cells, including endothelial progenitor cells and mesenchymal stem cells in small numbers. Naturally, these cells lack the specific markers of differentiated cells. In order to check the characteristics and identify the prototype (bone marrow), panels of different antibodies were placed, which are briefly mentioned. The results of the analysis were checked by BD FACS Calibur flow cytometer and read using CellQuest Pro software.(Complete results with specifications and identification analysis are also available if required).Panel 1: Marker of immature T lymphocyte cell lineCD3: 11.4%CD13: 3.72%Panel 2: Marker of immature B lymphocyte cell lineCD10: 1.00%CD20: 5.22%CD45: 30.8%Panel No. 3: Multivalent Stem Cell MarkerCD34: 0.317%CD117: 0.272%CD45: 55.2%Specification and identification of the final cell product:Since all cells in the bone marrow, including mononuclear cells, are responsible for producing lymphoid blood cell lines and monocytes, as well as non-hematopoietic stem cells, including mesenchymal stem cells, They are immature, polyvalent cells that originate from a common common ancestral cell. Therefore, they do not have specific markers of differentiated blood cells.To evaluate the characteristics and identify the cellular product, panels of different antibodies were placed, which are briefly mentioned. (Complete results with specifications and identification analysis are also available if required).Panel 1: Marker of immature T lymphocyte cell lineCD3: 62.0%CD13: 18.0%Panel 2: Marker of immature B lymphocyte cell lineCD10: 2.82%CD20: 8.59%CD45: 77.70%Panel No. 3: Multivalent Stem Cell MarkerCD34: 0.754%CD117: 0.709%CD45: 82.9%Selective coronary angiogram is performed and after determining the path of coronary arteries by an over the wire balloon, the initial part of each of the three main coronaries LAD, LCX and RCA is temporarily tight for less than 2 to 3 minutes based on ECG changes. (To reduce the speed of coronary blood flow and increase the residence time of the solution containing cells in the coronary tract) and 3 cc of the prepared solution is injected at low speed.All patients will be monitored for ECG changes and cardiac enzymes for up to 24 hours during and after the procedure. Hospitalization of patients continues until a completely stable clinical condition develops.Subsequent follow-ups of patients will be based on ECG, 2D echo and color Doppler + Tissue Doppler and Speckle tracking echo at intervals of 3 months, 6 months and 12 months. Follow-up results and patients' performance class will be recorded on Form One.At the end of one year of follow-up, patients will be statistically evaluated Ejection fraction. Timepoint: baseline, 1mo, 3 mo, 6mo. Method of measurement: Echocardiography. 6 Min walk test. Timepoint: baseline, 1mo, 3 mo, 6mo. Method of measurement: Test in pediatric cardiology ward. Speckle echocardiography. Timepoint: baseline, 1mo, 3 mo, 6mo. Method of measurement: echocardiography. Shiraz University of Medical Sciences Approved 2022-01-06 Ethics committee of Shiraz University of Medical Sciences Namazi hospital, Zand BLV Shiraz Fars Iran (Islamic Republic of)