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Allogenic Umbilical Cord Blood and Erythropoietin Combination Therapy for Cerebral Palsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sung Kwang Medical Foundation
ClinicalTrials.gov Identifier:
NCT01193660
First received: August 29, 2010
Last updated: March 1, 2012
Last verified: March 2012
Results First Received: October 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cerebral Palsy
Interventions: Biological: Umbilical Cord Blood Infusion
Drug: Erythropoietin Injection
Other: Active Rehabilitation
Other: Placebo Umbilical Cord Blood
Other: Placebo Erythropoietin

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Umbilical Cord Blood & Erythropoietin & Rehabilitation Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
Erythropoietin & Rehabilitation Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
Only Rehabilitation Active rehabilitation
Total Total of all reporting groups

Baseline Measures
   Umbilical Cord Blood & Erythropoietin & Rehabilitation   Erythropoietin & Rehabilitation   Only Rehabilitation   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   36   34   105 
Age 
[Units: Participants]
       
<=18 years   35   36   34   105 
Between 18 and 65 years   0   0   0   0 
>=65 years   0   0   0   0 
Age 
[Units: Months]
Mean (Standard Deviation)
 45.71  (18.91)   50.05  (24.45)   46.0  (19.58)   47.30  (21.07) 
Gender 
[Units: Participants]
       
Female   13   11   9   33 
Male   22   25   25   72 
Region of Enrollment 
[Units: Participants]
       
Korea, Republic of   35   36   34   105 


  Outcome Measures
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1.  Primary:   Changes in Motor Performance   [ Time Frame: Baseline -1 month - 3 months - 6 months ]

2.  Primary:   Changes in Standardized Gross Motor Function   [ Time Frame: Baseline - 1 month - 3 months - 6 months ]

3.  Secondary:   Changes in Cognitive Neurodevelopmental Outcome   [ Time Frame: Baseline -1 month - 3 months - 6 months ]

4.  Secondary:   Changes in Motor Neurodevelopmental Outcome   [ Time Frame: Baseline - 1 month - 3 months - 6 months ]

5.  Secondary:   Changes in Brain MRI   [ Time Frame: Baseline - 6 months ]

6.  Secondary:   Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism   [ Time Frame: Baseline - 2 weeks ]

7.  Secondary:   Changes in Functional Performance in Daily Activities   [ Time Frame: Baseline -1 month - 3 months - 6 months ]

8.  Secondary:   Changes in Functional Independence in Daily Activities   [ Time Frame: Baseline - 1 month - 3 months - 6 months ]

9.  Secondary:   Changes in Muscle Strength   [ Time Frame: Baseline - 1 month - 3 months - 6 months ]

10.  Secondary:   Changes in Hand Function   [ Time Frame: Baseline - 1 month - 3 months - 6 months ]

11.  Secondary:   Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Baseline - 1 month - 3 months - 6 months
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0  

Reporting Groups
  Description
Umbilical Cord Blood & Erythropoietin & Rehabilitation Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
Erythropoietin & Rehabilitation Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
Only Rehabilitation Active rehabilitation

Other Adverse Events
    Umbilical Cord Blood & Erythropoietin & Rehabilitation   Erythropoietin & Rehabilitation   Only Rehabilitation
Total, other (not including serious) adverse events       
# participants affected / at risk   30/35 (85.71%)   29/36 (80.56%)   32/34 (94.12%) 
Blood and lymphatic system disorders       
Anemia † 1       
# participants affected / at risk   1/35 (2.86%)   0/0   0/18 (0.00%) 
# events   1   0   0 
Ear and labyrinth disorders       
Otitis media acute † 1       
# participants affected / at risk   1/35 (2.86%)   1/14 (7.14%)   0/18 (0.00%) 
# events   1   1   0 
Eye disorders       
Conjunctival irritations † 1       
# participants affected / at risk   0/35 (0.00%)   1/14 (7.14%)   1/18 (5.56%) 
# events   0   1   2 
Gastrointestinal disorders       
Constipation † 1       
# participants affected / at risk   5/35 (14.29%)   4/14 (28.57%)   5/18 (27.78%) 
# events   5   4   5 
Dyspepsia † 1       
# participants affected / at risk   5/35 (14.29%)   2/36 (5.56%)   2/18 (11.11%) 
# events   5   2   2 
Nausea, vomiting † 1       
# participants affected / at risk   6/35 (17.14%)   5/36 (13.89%)   2/18 (11.11%) 
# events   6   5   2 
Diarrhea † 1       
# participants affected / at risk   6/35 (17.14%)   2/36 (5.56%)   2/18 (11.11%) 
# events   6   2   2 
Colitis † 1       
# participants affected / at risk   0/35 (0.00%)   1/14 (7.14%)   2/18 (11.11%) 
# events   0   1   2 
Anorexia † 1       
# participants affected / at risk   5/35 (14.29%)   2/36 (5.56%)   1/18 (5.56%) 
# events   5   2   1 
Infections and infestations       
Herpangina † 1       
# participants affected / at risk   0/35 (0.00%)   2/14 (14.29%)   1/18 (5.56%) 
# events   0   2   1 
Fever † 1       
# participants affected / at risk   12/35 (34.29%)   4/36 (11.11%)   8/18 (44.44%) 
# events   12   4   8 
Nervous system disorders       
Seizure † 1       
# participants affected / at risk   1/35 (2.86%)   3/36 (8.33%)   3/18 (16.67%) 
# events   1   6   7 
Febrile convulsioin † 1       
# participants affected / at risk   2/35 (5.71%)   1/14 (7.14%)   0/18 (0.00%) 
# events   3   1   0 
Psychiatric disorders       
Irritability † 1       
# participants affected / at risk   4/35 (11.43%)   0/14 (0.00%)   0/18 (0.00%) 
# events   4   0   0 
Insomnia † 1       
# participants affected / at risk   0/35 (0.00%)   1/36 (2.78%)   1/18 (5.56%) 
# events   0   1   1 
Respiratory, thoracic and mediastinal disorders       
Bronchitis † 1       
# participants affected / at risk   4/35 (11.43%)   4/14 (28.57%)   3/18 (16.67%) 
# events   4   4   3 
Pneumonia † 1       
# participants affected / at risk   6/35 (17.14%)   0/14 (0.00%)   0/18 (0.00%) 
# events   6   0   0 
Upper respiratory tract infection † 1       
# participants affected / at risk   18/35 (51.43%)   19/36 (52.78%)   21/34 (61.76%) 
# events   20   23   24 
Hypoxia † 1 [3]       
# participants affected / at risk   3/35 (8.57%)   1/36 (2.78%)   1/18 (5.56%) 
# events   3   1   1 
Skin and subcutaneous tissue disorders       
Dermatitis † 1       
# participants affected / at risk   0/35 (0.00%)   2/36 (5.56%)   2/18 (11.11%) 
# events   0   2   2 
Urticaria † 1       
# participants affected / at risk   2/35 (5.71%)   1/14 (7.14%)   4/18 (22.22%) 
# events   2   1   4 
Hirsuitism † 1       
# participants affected / at risk   2/35 (5.71%)   0/0   0/0 
# events   2   0   0 
Alopecia † 1       
# participants affected / at risk   1/35 (2.86%)   0/0   0/0 
# events   1   0   0 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 14.1
[3] Temporary O2 desaturation(89-91%) at the end of UCB infusion in UCB group; O2 desaturation(91%) shortly during sedation for PET in EPO group; O2 desaturation(71-95%) intermittently during 47 min maybe from postictal respiratory depression in control



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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