Cerebral PalsyPhase 2NCT03826498
Allogenic Cord Blood Transfusion in Patients With Cerebral Palsy
A Phase 2 study testing CP CB-MNC injection and Standard therapy in people with Cerebral Palsy, run by State-Financed Health Facility "Samara Regional Medical Center Dinasty" at 1 site in Russia.
Trial summary
Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability. Many experimental animal studies have revealed that umbilical cord blood is useful to repair neurological injury in brain. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- CP CB-MNC injection and Standard therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 12 Jan 2018to 26 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Confirmed diagnosis: Cerebral Palsy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Olga Tyumina, M.D, PhD contact
Russia1 site, 1 recruiting
- Recruiting
Medical Centre Dinasty
Samara, 443095
Stanislav Volchkov, MD, +78469564455, quality@cordbank.ru
Pavel Ovchinnikov, MD, +78469564455
About this study
Official title: Efficiency Evaluation of Allogenic Umbilical Cord Blood Mononuclear Cells (UCB-MNC) Transfusion in Patients With Autism
Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.
Many experimental animal studies have revealed that umbilical cord blood is useful to repair neurological injury in brain.
On the basis of many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy.
Read the detailed description
Cerebral palsy (CP) is a group of neurodevelopmental conditions with abnormal movement and posture resulted from a non-progressive cerebral disturbance. It is the most common cause of motor disability in childhood. Most therapies are palliative rather than restorative. Umbilical cord blood (UCB) may be used as restorative approach for children with CP.
Many experimental animal studies have revealed that UCB is beneficial to improve and repair neurological injuries, this effect achieved due to immune regulation and angiogenesis as well as the neuroprotective effect.
Based on animal studies and some clinical trials, UCB is suggested as a potential therapy for children with CP.
This study is prospective, non randomized (open label) with control group.
- Conditions
- Cerebral Palsy
- Being tested
- CP CB-MNC injection, Standard therapy
- Keywords
- Cerebral palsy, CP, Cord Blood, Stem cells
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP CB-MNC injectionBiological
CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.
Standard therapyOther
The standard therapy can include drugs, special psychology training etc.
| Study group | Role | What they receive |
|---|---|---|
| CP CB-MNC injection | Experimental | CP CB-MNC injection from different donors and standard therapy. Receives: Biological: CP CB-MNC injection; Other: Standard therapy |
| Standard therapy | Other | Patients with standard therapy as control group Receives: Other: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with non-serious and serious adverse events
Safety assessment such as adverse events will be registered. Adverse events will be monitored during all trial.
Measured: 6 month
Changes in Standardized Gross Motor Function 66 (GMFM-66) Score for all child.
GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying \& rolling, sitting, crawling \& kneeling, standing, walking, running \& jumping (range: 0~100 , Higher value means better gross motor function). We reported changes of GMFM between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones. This test will be acquired for all child.
Measured: 1, 3, 6 month
Changes in Cognitive Neurodevelopmental Outcome for child before 3yrs
Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (higher value means better mental function: 0 - worst, 178 - best). We reported changes of BSID-II Mental Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.This test will be acquired for child before 3yrs.
Measured: 1, 3, 6 month
Changes in The Infant Toddler Quality of Life Questionnaire for child above 3yrs.
ITQOL - the 47-item short-form (ITQOL-SF47) developed for use in infants and toddlers from 2-months-to-5 years of age. Form scores physical, mental and social well being/ For each concept, item responses are scored, summed, and transformed on a scale from 0 (worst health) to 100 (best health). Changes in completed questionnaire will be assessed. This test will be acquired for child above 3yrs.
Measured: 1, 3, 6 month
Changes in Ashworth scale score for all child.
The Ashworth scale (AS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity scoring, where:
0 No increase in tone;
- Slight increase in tone giving catch when the limb is moved in flexion and extension;
- More marked increase in tone, but limb is easily flexed;
- Considerable increases in tone, passive movement difficult;
- Limb rigid in flexion or extension. This test will be acquired for child above 3yrs.
Measured: 1, 3, 6 month
Secondary outcomes (1)
Number of Participants with Chimerism (longevity) of infused cell
Chimerism study to detect the longevity of infused donor cells and predict effectiveness of treatment. This study measure DNA of donor cells will in patients blood at the end of protocol. Absence of donor DNA suggest no chimerism.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start12 Jan 2018
- Primary completion26 Jan 2024 (estimated)
- Study completion26 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State-Financed Health Facility "Samara Regional Medical Center Dinasty"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volchkov Stanislav, State-Financed Health Facility "Samara Regional Medical Center Dinasty"
- Investigators
- STANISLAV VOLCHKOV, MD, PhD, Principal investigator, Medical Centre Dinasty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826498
- Sponsor's protocol ID
- 12102017
- Status last verified
- Jan 2023
- First submitted
- 22 Jan 2019
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency Evaluation of Allogenic Umbilical Cord Blood Mononuclear Cells (UCB-MNC) Transfusion in Patients With Autism
- ClinicalTrials.gov ID
- NCT03826498
- Acronym / sponsor ID
- 12102017
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, CP, Cord Blood, Stem cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- State-Financed Health Facility "Samara Regional Medical Center Dinasty"University, hospital or other
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 26 Jan 2024 (estimated)
- Study completion
- 26 Dec 2024 (estimated)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.
Many experimental animal studies have revealed that umbilical cord blood is useful to repair neurological injury in brain.
On the basis of many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy.
Detailed description
Cerebral palsy (CP) is a group of neurodevelopmental conditions with abnormal movement and posture resulted from a non-progressive cerebral disturbance. It is the most common cause of motor disability in childhood. Most therapies are palliative rather than restorative. Umbilical cord blood (UCB) may be used as restorative approach for children with CP.
Many experimental animal studies have revealed that UCB is beneficial to improve and repair neurological injuries, this effect achieved due to immune regulation and angiogenesis as well as the neuroprotective effect.
Based on animal studies and some clinical trials, UCB is suggested as a potential therapy for children with CP.
This study is prospective, non randomized (open label) with control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CP CB-MNC injection | Experimental | Biological: CP CB-MNC injection, Other: Standard therapyCP CB-MNC injection from different donors and standard therapy. |
| Standard therapy | Other | Other: Standard therapyPatients with standard therapy as control group |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Confirmed diagnosis: Cerebral Palsy.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP CB-MNC injectionCB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals. | Biological | CP CB-MNC injection |
| Standard therapyThe standard therapy can include drugs, special psychology training etc. | Other | CP CB-MNC injection, Standard therapy |
Primary outcome
Number of participants with non-serious and serious adverse events
Time frame: 6 month
Safety assessment such as adverse events will be registered. Adverse events will be monitored during all trial.
Changes in Standardized Gross Motor Function 66 (GMFM-66) Score for all child.
Time frame: 1, 3, 6 month
GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying \& rolling, sitting, crawling \& kneeling, standing, walking, running \& jumping (range: 0~100 , Higher value means better gross motor function). We reported changes of GMFM between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones. This test will be acquired for all child.
Changes in Cognitive Neurodevelopmental Outcome for child before 3yrs
Time frame: 1, 3, 6 month
Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (higher value means better mental function: 0 - worst, 178 - best). We reported changes of BSID-II Mental Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.This test will be acquired for child before 3yrs.
Changes in The Infant Toddler Quality of Life Questionnaire for child above 3yrs.
Time frame: 1, 3, 6 month
ITQOL - the 47-item short-form (ITQOL-SF47) developed for use in infants and toddlers from 2-months-to-5 years of age. Form scores physical, mental and social well being/ For each concept, item responses are scored, summed, and transformed on a scale from 0 (worst health) to 100 (best health). Changes in completed questionnaire will be assessed. This test will be acquired for child above 3yrs.
Changes in Ashworth scale score for all child.
Time frame: 1, 3, 6 month
The Ashworth scale (AS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity scoring, where: 0 No increase in tone; 1. Slight increase in tone giving catch when the limb is moved in flexion and extension; 2. More marked increase in tone, but limb is easily flexed; 3. Considerable increases in tone, passive movement difficult; 4. Limb rigid in flexion or extension. This test will be acquired for child above 3yrs.
1 secondary outcome
Number of Participants with Chimerism (longevity) of infused cell
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Tyumina, M.D, PhD contact
STANISLAV VOLCHKOV, MD, PhD principal investigator
Medical Centre Dinasty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP CB-MNC injection and Standard therapy in people with Cerebral Palsy, run by State-Financed Health Facility "Samara Regional Medical Center Dinasty" at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact STANISLAV VOLCHKOV, MD, PhD (+79608159408, bioen07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with non-serious and serious adverse events (time frame: 6 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.