Autism, Autism Spectrum Disorder
Conditions
Keywords
Autism, ASD, Cord blood
Brief summary
Autism is one of those disorders in Autism spectrum disorders (ASD), which characterized by social interaction abnormalities, impaired verbal and non-verbal communication, and repetitive, obsessive behavior, while the therapeutic effect of current treatments remains limited progress. The possible reason for ASD is neural hypoperfusion and immune deregulation. The Human Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy. In this study, the safety and efficacy of hUCB-MNCs infusion will be evaluated in patients with Autism.
Detailed description
Autism Spectrum Disorders (ASD) are heterogeneous neuro-developed disorders. Autism is the most common disorder of the diseases characterized by dysfunctions in response social interaction and communication, as well as the presence of repetitive and stereotyped behaviors. Recent reports of a sharp increase in the number of children with autism. The exact etiology of autism remains unclear. Compliance, the definition of effective treatments for autism is particularly difficult. Although it has been understood, it can be a question of immune dysregulation. Examination of the inflammatory cytokines, dysfunction of the immune system and the immune system. The Human Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy. The Our study suggest that infusion of cord blood mononuclear cells will affect Autism.
Interventions
BIOLOGICALASD CB-MNC injection.
CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.
OTHERStandard therapy.
The standard therapy can include drugs, special psychology training etc.
Sponsors
State-Financed Health Facility Samara Regional Medical Center Dinasty
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is prospective, non-randomized (open label) with control group study. The total 20 patient will be enrolled in this study. In 10 patient with ASD will be infused with umbilical corb blood. Other 10 patient with ASD will be treated with standard therapy (control group).
Eligibility
Sex/Gender
ALL
Age
3 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis: autistic type disorder (ASD). * Systemic speech underdevelopment * The presence of attention deficit hyperactivity disorder as a comorbid state * Cognitive impairment
Exclusion criteria
* organic pathology of the brain according to CT, MRI * the presence of the following diseases in history: heart failure in the stage of decompensation, stroke in history less than 1 year ago, blood diseases; * decompensation of chronic and endocrinological diseases; * acute respiratory viral and bacterial infections, period less than 1 month after the acute phase. * HIV infection, hepatitis B and C. * oncological diseases, chemotherapy in the anamnesis; * tuberculosis. * Severe form of intellectual disability. * Cerebral palsy. * epilepsy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | 24hrs post transfusion | Safety assessment. The adverse events rate will be assessed in all patients. |
| Autism Treatment Evaluation Checklist (ATEC). | score at baseline, 1, 2, 6, 12 months | The ATEC is designed to measure changes in the severity of ASD in response to treatment. A total score and 4 subscale scores are reported. Questions in the first 3 subscales are scored using a 0-3 scale (not true/partially true/absolutely true). The 4 subscale, Health/Physical/Behavior, is scored using a 0-4 point scale (Not a problem/Minor problem/Moderate problem/Serious problem). The first subscale, Speech/Language/Communication, contains 14 items where the score ranges from 0-28 points. The Sociability subscale contains 20 items and participants can score from 0-40. The third subscale, Sensory/Cognitive awareness, has 18 items and scores range from 0-36. Finally, the Health/Physical/Behavior subscale contains 25 items and scores range from 0-75. The scores from each subscale are combined in order to calculate a Total Score, which ranges from 0 to179 points. A lower score indicates less severe symptoms of ASD and a higher score correlates with more severe symptoms of ASD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cytokine Analysis. | score at baseline, 1, 2, 6 months | IL1b, IL6, TNF-alpha, IL8, y-IFN measure in patient peripheral blood |
| Immune Status as Determined by Percentage of Peripheral Blood Cells | score at baseline, 6 month | Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (%) |
| Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells | score at baseline, 6 month | Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (absolute v.) |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ASD CB-MNC Injection. ASD CB-MNC injection from different donors and standard therapy.
ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.
Standard therapy.: The standard therapy can include drugs, special psychology training etc. | 10 |
| Standard Therapy. Patients with standard therapy as control group.
Standard therapy.: The standard therapy can include drugs, special psychology training etc. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Standard Therapy. | Total | ASD CB-MNC Injection. |
|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | 20 Participants | 10 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 7.80 years | 7.87 years | 7.95 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Russia | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 8 Participants | 17 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 6 / 10 | 8 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion
Safety assessment. The adverse events rate will be assessed in all patients.
Time frame: 24hrs post transfusion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ASD CB-MNC Injection. | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Oliguria | 0 participants |
| ASD CB-MNC Injection. | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Skin itching | 0 participants |
| ASD CB-MNC Injection. | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Hematuria | 0 participants |
| ASD CB-MNC Injection. | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Hypotension | 0 participants |
| ASD CB-MNC Injection. | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Jaundice | 0 participants |
| ASD CB-MNC Injection. | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Hives | 0 participants |
| ASD CB-MNC Injection. | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Nausea | 0 participants |
| ASD CB-MNC Injection. | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Increase in body temperature | 0 participants |
| ASD CB-MNC Injection. | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Vomiting | 0 participants |
| ASD CB-MNC Injection. | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Post-transfusion purple | 0 participants |
| ASD CB-MNC Injection. | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Dizziness | 0 participants |
| ASD CB-MNC Injection. | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Dyspnea | 0 participants |
| ASD CB-MNC Injection. | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Pain at injection site | 1 participants |
| ASD CB-MNC Injection. | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Oedema Quinque | 0 participants |
| ASD CB-MNC Injection. | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Anxiety | 2 participants |
| ASD CB-MNC Injection. | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Chill | 0 participants |
| Control Group | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Anxiety | 0 participants |
| Control Group | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Increase in body temperature | 0 participants |
| Control Group | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Hypotension | 0 participants |
| Control Group | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Dyspnea | 0 participants |
| Control Group | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Skin itching | 0 participants |
| Control Group | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Hives | 0 participants |
| Control Group | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Post-transfusion purple | 0 participants |
| Control Group | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Oedema Quinque | 0 participants |
| Control Group | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Oliguria | 0 participants |
| Control Group | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Hematuria | 0 participants |
| Control Group | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Jaundice | 0 participants |
| Control Group | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Nausea | 0 participants |
| Control Group | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Vomiting | 0 participants |
| Control Group | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Dizziness | 0 participants |
| Control Group | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Pain at injection site | 0 participants |
| Control Group | A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion | Chill | 0 participants |
Primary
Autism Treatment Evaluation Checklist (ATEC).
The ATEC is designed to measure changes in the severity of ASD in response to treatment. A total score and 4 subscale scores are reported. Questions in the first 3 subscales are scored using a 0-3 scale (not true/partially true/absolutely true). The 4 subscale, Health/Physical/Behavior, is scored using a 0-4 point scale (Not a problem/Minor problem/Moderate problem/Serious problem). The first subscale, Speech/Language/Communication, contains 14 items where the score ranges from 0-28 points. The Sociability subscale contains 20 items and participants can score from 0-40. The third subscale, Sensory/Cognitive awareness, has 18 items and scores range from 0-36. Finally, the Health/Physical/Behavior subscale contains 25 items and scores range from 0-75. The scores from each subscale are combined in order to calculate a Total Score, which ranges from 0 to179 points. A lower score indicates less severe symptoms of ASD and a higher score correlates with more severe symptoms of ASD.
Time frame: score at baseline, 1, 2, 6, 12 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Speech/Language/Communication at 2 months | 7 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Sensory/Cognitive Awareness at 6 months | 12 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Sociability at 2 months | 9 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Sensory/Cognitive Awareness at 12 months | 12 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Speech/Language/Communication at 12 months | 12 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Health/ Physical Development/Behaviour at baseline | 24 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Sociability at 6 months | 11 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Health/ Physical Development/Behaviour at 1 months | 16 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Speech/Language/Communication at 1 months | 11 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Health/ Physical Development/Behaviour at 2 months | 14 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Sociability at 12 months | 12 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Health/ Physical Development/Behaviour at 6 months | 16 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Sociability at baseline | 11 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Health/ Physical Development/Behaviour at 12months | 13 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Sensory/Cognitive Awareness at baseline | 13 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Total score at baseline | 63 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Speech/Language/Communication at 6 months | 11 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Total score at 1 months | 55 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Sensory/Cognitive Awareness at 1 months | 10 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Total score at 2 months | 44 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Sociability at 1 months | 11 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Total score at 6 months | 55 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Sensory/Cognitive Awareness at 2 months | 10 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Total score at 12 months | 55 score on a scale |
| ASD CB-MNC Injection. | Autism Treatment Evaluation Checklist (ATEC). | Speech/Language/Communication at baseline | 14 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Total score at 12 months | 71 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Speech/Language/Communication at baseline | 14 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Speech/Language/Communication at 1 months | 14 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Speech/Language/Communication at 2 months | 16 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Speech/Language/Communication at 6 months | 14 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Speech/Language/Communication at 12 months | 15 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Sociability at baseline | 11 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Sociability at 1 months | 12 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Sociability at 2 months | 11 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Sociability at 6 months | 13 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Sociability at 12 months | 14 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Sensory/Cognitive Awareness at baseline | 12 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Sensory/Cognitive Awareness at 1 months | 11 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Sensory/Cognitive Awareness at 2 months | 11 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Sensory/Cognitive Awareness at 6 months | 14 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Sensory/Cognitive Awareness at 12 months | 13 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Health/ Physical Development/Behaviour at baseline | 24 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Health/ Physical Development/Behaviour at 1 months | 24 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Health/ Physical Development/Behaviour at 2 months | 23 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Health/ Physical Development/Behaviour at 6 months | 24 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Health/ Physical Development/Behaviour at 12months | 22 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Total score at baseline | 62 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Total score at 1 months | 65 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Total score at 2 months | 68 score on a scale |
| Control Group | Autism Treatment Evaluation Checklist (ATEC). | Total score at 6 months | 70 score on a scale |
Comparison: The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartilep-value: 0.049367Wilcoxon (Mann-Whitney)
Comparison: The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0 and MS Office Excel 2007. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile.p-value: 0.004072Wilcoxon (Mann-Whitney)
Comparison: The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0 and MS Office Excel 2007. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile.p-value: 0.017258Wilcoxon (Mann-Whitney)
Comparison: The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartilep-value: 0.03121Wilcoxon (Mann-Whitney)
Comparison: The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartilep-value: 0.00194Wilcoxon (Mann-Whitney)
Comparison: The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartilep-value: 0.03121Wilcoxon (Mann-Whitney)
Comparison: The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartilep-value: 0.01133Wilcoxon (Mann-Whitney)
Secondary
Cytokine Analysis.
IL1b, IL6, TNF-alpha, IL8, y-IFN measure in patient peripheral blood
Time frame: score at baseline, 1, 2, 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ASD CB-MNC Injection. | Cytokine Analysis. | y-IFN pg/ml at baseline | 0 pg/mL |
| ASD CB-MNC Injection. | Cytokine Analysis. | y-IFN pg/ml at 1 months | 0 pg/mL |
| ASD CB-MNC Injection. | Cytokine Analysis. | y-IFN pg/ml at 2 months | 0 pg/mL |
| ASD CB-MNC Injection. | Cytokine Analysis. | y-IFN pg/ml at 6 months | 0 pg/mL |
| ASD CB-MNC Injection. | Cytokine Analysis. | IL1b pg/ml at baseline | 1.228 pg/mL |
| ASD CB-MNC Injection. | Cytokine Analysis. | IL1b pg/ml at 1 months | 1.279 pg/mL |
| ASD CB-MNC Injection. | Cytokine Analysis. | IL1b pg/ml at 2 months | 1.9675 pg/mL |
| ASD CB-MNC Injection. | Cytokine Analysis. | IL1b pg/ml at 6 months | 2.794 pg/mL |
| ASD CB-MNC Injection. | Cytokine Analysis. | IL6 pg/ml at baseline | 1.0225 pg/mL |
| ASD CB-MNC Injection. | Cytokine Analysis. | IL6 pg/ml at 1 months | 0.673 pg/mL |
| ASD CB-MNC Injection. | Cytokine Analysis. | IL6 pg/ml at 2 months | 0.5625 pg/mL |
| ASD CB-MNC Injection. | Cytokine Analysis. | IL6pg/ml at 6 months | 0.7455 pg/mL |
| ASD CB-MNC Injection. | Cytokine Analysis. | IL8 pg/ml at baseline | 3.9175 pg/mL |
| ASD CB-MNC Injection. | Cytokine Analysis. | IL8 pg/ml at 1 months | 2.7985 pg/mL |
| ASD CB-MNC Injection. | Cytokine Analysis. | IL8 pg/ml at 2 months | 2.7485 pg/mL |
| ASD CB-MNC Injection. | Cytokine Analysis. | IL8 pg/ml at 6 months | 4.7975 pg/mL |
| ASD CB-MNC Injection. | Cytokine Analysis. | TNF-alpha pg/ml at baseline | 0 pg/mL |
| ASD CB-MNC Injection. | Cytokine Analysis. | TNF-alpha pg/ml at 1 months | 0 pg/mL |
| ASD CB-MNC Injection. | Cytokine Analysis. | TNF-alpha pg/ml at 2 months | 0 pg/mL |
| ASD CB-MNC Injection. | Cytokine Analysis. | TNF-alpha pg/ml at 6 months | 0.0 pg/mL |
Secondary
Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells
Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (absolute v.)
Time frame: score at baseline, 6 month
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ASD CB-MNC Injection. | Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells | CD 3+ at baseline | 1450.355 cells/µl |
| ASD CB-MNC Injection. | Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells | CD 3+at 6 months | 1829.11 cells/µl |
| ASD CB-MNC Injection. | Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells | CD 3+CD8+ at baseline | 598.48 cells/µl |
| ASD CB-MNC Injection. | Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells | CD 3+CD8+ at 6 months | 654.385 cells/µl |
| ASD CB-MNC Injection. | Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells | CD 3+CD4+ at baseline | 750.08 cells/µl |
| ASD CB-MNC Injection. | Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells | CD 3+CD4+ at 6 months | 877.095 cells/µl |
| ASD CB-MNC Injection. | Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells | CD 3+ CD4+CD8+ at baseline | 5.555 cells/µl |
| ASD CB-MNC Injection. | Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells | CD 3+ CD4+CD8+ at 6 months | 8.656 cells/µl |
| ASD CB-MNC Injection. | Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells | CD 16+CD56+ at baseline | 321.89 cells/µl |
| ASD CB-MNC Injection. | Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells | CD 16+CD56+ at 6 months | 476.055 cells/µl |
| ASD CB-MNC Injection. | Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells | СD19+ at baseline | 457.505 cells/µl |
| ASD CB-MNC Injection. | Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells | СD19+ at 6 months | 506.365 cells/µl |
Secondary
Immune Status as Determined by Percentage of Peripheral Blood Cells
Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (%)
Time frame: score at baseline, 6 month
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ASD CB-MNC Injection. | Immune Status as Determined by Percentage of Peripheral Blood Cells | CD 3+(%) at baseline | 61.24 percentage of cells |
| ASD CB-MNC Injection. | Immune Status as Determined by Percentage of Peripheral Blood Cells | CD 3+(%) at 6 months | 63.71 percentage of cells |
| ASD CB-MNC Injection. | Immune Status as Determined by Percentage of Peripheral Blood Cells | СD3+СD8+ (%) at baseline | 24.33 percentage of cells |
| ASD CB-MNC Injection. | Immune Status as Determined by Percentage of Peripheral Blood Cells | СD3+СD8+(%) at 6 months | 25.345 percentage of cells |
| ASD CB-MNC Injection. | Immune Status as Determined by Percentage of Peripheral Blood Cells | СD3+СD4+ (%) at baseline | 32.835 percentage of cells |
| ASD CB-MNC Injection. | Immune Status as Determined by Percentage of Peripheral Blood Cells | СD3+СD4+(%) at 6 months | 32.55 percentage of cells |
| ASD CB-MNC Injection. | Immune Status as Determined by Percentage of Peripheral Blood Cells | СD3+СD4+СD8+ (%) at baseline | 0.215 percentage of cells |
| ASD CB-MNC Injection. | Immune Status as Determined by Percentage of Peripheral Blood Cells | СD3+СD4+СD8+(%) at 6 months | 0.31 percentage of cells |
| ASD CB-MNC Injection. | Immune Status as Determined by Percentage of Peripheral Blood Cells | СD16+СD56+(%) at baseline | 15.19 percentage of cells |
| ASD CB-MNC Injection. | Immune Status as Determined by Percentage of Peripheral Blood Cells | СD16+СD56+(%) at 6 months | 16.05 percentage of cells |
| ASD CB-MNC Injection. | Immune Status as Determined by Percentage of Peripheral Blood Cells | СD19+(%) at baseline | 19.29 percentage of cells |
| ASD CB-MNC Injection. | Immune Status as Determined by Percentage of Peripheral Blood Cells | СD19+ (%) at 6 months | 17.255 percentage of cells |