A Phase 1/2 interventional study of ASD CB-MNC injection. and Standard therapy. in Autism Spectrum Disorder and Autism, sponsored by State-Financed Health Facility "Samara Regional Medical Center Dinasty". Completed at 1 site in Russian Federation. Open to participants aged 3 Years to 15 Years. Per ClinicalTrials.gov, last updated 2020-11-19.
Sponsored by State-Financed Health Facility "Samara Regional Medical Center Dinasty" · Phase 1/2, Interventional, and Treatment
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.
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 20 is below the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →State-Financed Health Facility "Samara Regional Medical Center Dinasty" is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ASD CB-MNC injection from different donors and standard therapy.
Biological: ASD CB-MNC injection. · Other: Standard therapy.
Patients with standard therapy as control group.
Other: Standard therapy.
CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.
The standard therapy can include drugs, special psychology training etc.
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
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
Cytokine Analysis.
IL1b, IL6, TNF-alpha, IL8, y-IFN measure in patient peripheral blood
Time frame: score at baseline, 1, 2, 6 months
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
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
| Milestone | ASD CB-MNC Injection. | Standard Therapy. |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
Safety assessment. The adverse events rate will be assessed in all patients.
| participants | ASD CB-MNC Injection. | Control Group |
|---|---|---|
| Increase in body temperature | 0 | 0 |
| Chill | 0 | 0 |
| Hypotension | 0 | 0 |
| Dyspnea | 0 | 0 |
| Skin itching | 0 | 0 |
| Hives | 0 | 0 |
| Post-transfusion purple | 0 | 0 |
| Oedema Quinque | 0 | 0 |
| Oliguria | 0 | 0 |
| Hematuria | 0 | 0 |
| Jaundice | 0 | 0 |
| Nausea | 0 | 0 |
| Vomiting | 0 | 0 |
| Dizziness | 0 | 0 |
| Pain at injection site | 1 | 0 |
| Anxiety | 2 | 0 |
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.
| score on a scale | ASD CB-MNC Injection. | Standard Therapy. |
|---|---|---|
| Speech/Language/Communication at baseline | 14 (10 to 20) | 14 (13 to 21) |
| Speech/Language/Communication at 1 months | 11 (5 to 18) | 14 (11 to 21) |
| Speech/Language/Communication at 2 months | 7 (2 to 17) | 16 (14 to 22) |
| Speech/Language/Communication at 6 months | 11 (5 to 22) | 14 (12 to 20) |
| Speech/Language/Communication at 12 months | 12 (6 to 17) | 15 (13 to 20) |
| Sociability at baseline | 11 (9 to 17) | 11 (9 to 15) |
| Sociability at 1 months | 11 (9 to 13) | 12 (9 to 15) |
| Sociability at 2 months | 9 (6 to 14) | 11 (10 to 14) |
| Sociability at 6 months | 11 (8 to 14) | 13 (10 to 15) |
| Sociability at 12 months | 12 (8 to 14) | 14 (11 to 14) |
| Sensory/Cognitive Awareness at baseline | 13 (9 to 14) | 12 (10 to 15) |
| Sensory/Cognitive Awareness at 1 months | 10 (6 to 15) | 11 (10 to 17) |
| Sensory/Cognitive Awareness at 2 months | 10 (5 to 11) | 11 (11 to 16) |
| Sensory/Cognitive Awareness at 6 months | 12 (8 to 14) | 14 (11 to 16) |
| Sensory/Cognitive Awareness at 12 months | 12 (7 to 13) | 13 (11 to 17) |
| Health/ Physical Development/Behaviour at baseline | 24 (19 to 30) | 24 (19 to 30) |
| Health/ Physical Development/Behaviour at 1 months | 16 (13 to 21) | 24 (19 to 30) |
| Health/ Physical Development/Behaviour at 2 months | 14 (7 to 18) | 23 (19 to 30) |
| Health/ Physical Development/Behaviour at 6 months | 16 (13 to 25) | 24 (19 to 30) |
| Health/ Physical Development/Behaviour at 12months | 13 (10 to 17) | 22 (19 to 30) |
| Total score at baseline | 63 (56 to 66) | 62 (59 to 73) |
| Total score at 1 months | 55 (43 to 60) | 65 (60 to 72) |
| Total score at 2 months | 44 (31 to 57) | 68 (59 to 76) |
| Total score at 6 months | 55 (49 to 65) | 70 (60 to 82) |
| Total score at 12 months | 55 (38 to 61) | 71 (60 to 81) |
IL1b, IL6, TNF-alpha, IL8, y-IFN measure in patient peripheral blood
| pg/mL | ASD CB-MNC Injection. |
|---|---|
| y-IFN pg/ml at baseline | 0 (0 to 0) |
| y-IFN pg/ml at 1 months | 0 (0 to 0) |
| y-IFN pg/ml at 2 months | 0 (0 to 0) |
| y-IFN pg/ml at 6 months | 0 (0 to 0) |
| IL1b pg/ml at baseline | 1.228 (0 to 2.62) |
| IL1b pg/ml at 1 months | 1.279 (0 to 3.117) |
| IL1b pg/ml at 2 months | 1.9675 (0.095 to 3.251) |
| IL1b pg/ml at 6 months | 2.794 (0.396 to 3.103) |
| IL6 pg/ml at baseline | 1.0225 (0.43 to 2.168) |
| IL6 pg/ml at 1 months | 0.673 (0.392 to 2.076) |
| IL6 pg/ml at 2 months | 0.5625 (0.195 to 0.753) |
| IL6pg/ml at 6 months | 0.7455 (0.494 to 0.863) |
| IL8 pg/ml at baseline | 3.9175 (1.913 to 9.822) |
| IL8 pg/ml at 1 months | 2.7985 (2.157 to 5.341) |
| IL8 pg/ml at 2 months | 2.7485 (1.197 to 3.348) |
| IL8 pg/ml at 6 months | 4.7975 (3.507 to 38.388) |
| TNF-alpha pg/ml at baseline | 0 (0 to 0) |
| TNF-alpha pg/ml at 1 months | 0 (0 to 0) |
| TNF-alpha pg/ml at 2 months | 0 (0 to 0) |
| TNF-alpha pg/ml at 6 months | 0.0 (0 to 0) |
Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (%)
| percentage of cells | ASD CB-MNC Injection. |
|---|---|
| CD 3+(%) at baseline | 61.24 (58.55 to 66.59) |
| CD 3+(%) at 6 months | 63.71 (58.56 to 67.83) |
| СD3+СD8+ (%) at baseline | 24.33 (22.36 to 25.58) |
| СD3+СD8+(%) at 6 months | 25.345 (20.19 to 26.15) |
| СD3+СD4+ (%) at baseline | 32.835 (29.14 to 36.3) |
| СD3+СD4+(%) at 6 months | 32.55 (30.26 to 35.46) |
| СD3+СD4+СD8+ (%) at baseline | 0.215 (0.19 to 0.25) |
| СD3+СD4+СD8+(%) at 6 months | 0.31 (0.25 to 0.42) |
| СD16+СD56+(%) at baseline | 15.19 (7.29 to 21.08) |
| СD16+СD56+(%) at 6 months | 16.05 (11.47 to 21) |
| СD19+(%) at baseline | 19.29 (17.46 to 21.67) |
| СD19+ (%) at 6 months | 17.255 (16.25 to 18.68) |
Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (absolute v.)
| cells/µl | ASD CB-MNC Injection. |
|---|---|
| CD 3+ at baseline | 1450.355 (1364.77 to 2163.81) |
| CD 3+at 6 months | 1829.11 (1507.34 to 2312.87) |
| CD 3+CD8+ at baseline | 598.48 (481.48 to 790.19) |
| CD 3+CD8+ at 6 months | 654.385 (600.56 to 819.81) |
| CD 3+CD4+ at baseline | 750.08 (649.35 to 1197.94) |
| CD 3+CD4+ at 6 months | 877.095 (752.35 to 1197.99) |
| CD 3+ CD4+CD8+ at baseline | 5.555 (3.59 to 7.09) |
| CD 3+ CD4+CD8+ at 6 months | 8.656 (7.46 to 10.93) |
| CD 16+CD56+ at baseline | 321.89 (188.46 to 550.36) |
| CD 16+CD56+ at 6 months | 476.055 (306.37 to 607.71) |
| СD19+ at baseline | 457.505 (431.81 to 839.35) |
| СD19+ at 6 months | 506.365 (392.8 to 650.88) |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ASD CB-MNC Injection. | 0/10 (0%) | 0/10 (0%) | 6/10 (60%) |
| Standard Therapy. | 0/10 (0%) | 0/10 (0%) | 8/10 (80%) |
| Event | ASD CB-MNC Injection. | Standard Therapy. |
|---|---|---|
| Infectious natureRespiratory, thoracic and mediastinal disorders | 5/10 | 4/10 |
| Infectious natureGastrointestinal disorders | 2/10 | 1/10 |
| NON Infectious natureGastrointestinal disorders | 1/10 | 2/10 |
| NON Infectious natureNervous system disorders | 2/10 | 1/10 |
| HypersensitivityImmune system disorders | 1/10 | 2/10 |
| NON Infectious natureRespiratory, thoracic and mediastinal disorders | 1/10 | 1/10 |
| NON Infectious natureMusculoskeletal and connective tissue disorders | 0/10 | 1/10 |
| NON Infectious natureRenal and urinary disorders | 1/10 | 0/10 |
| Psychiatric symptomsPsychiatric disorders | 1/10 | 1/10 |
| Infectious natureCardiac disorders | 0/10 | 0/10 |
| Age, Categorical(Participants) | ASD CB-MNC Injection. | Standard Therapy. | Total |
|---|---|---|---|
| <=18 years | 10 | 10 | 20 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | ASD CB-MNC Injection. | Standard Therapy. | Total |
|---|---|---|---|
| Mean | 7.95 (4.5 to 14) | 7.80 (4.3 to 13) | 7.87 (4.3 to 14) |
| Sex: Female, Male(Participants) | ASD CB-MNC Injection. | Standard Therapy. | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 9 | 8 | 17 |
| Race and Ethnicity Not Collected(Participants) | ASD CB-MNC Injection. | Standard Therapy. | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | ASD CB-MNC Injection. | Standard Therapy. | Total |
|---|---|---|---|
| Russia | 10 | 10 | 20 |
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State-Financed Health Facility "Samara Regional Medical Center Dinasty"