This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

HomeBrowseAboutFAQs
Log In
Sign Up
Cerebral Palsy

A Study of UCB and MSCs in Children With CP: ACCeNT-CP

Sponsored by Joanne Kurtzberg, MD

About this trial

Last updated 4 years ago

Study ID

Pro00089362

Status

Completed

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

No

Accepting

18-75 Years
24 to 60 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 years ago

What is this trial about?

The main purpose of this study is to estimate change in motor function 12 months after treatment with a single dose of allogeneic umbilical cord blood (AlloCB) or repeated doses of umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) in children with cerebral palsy. In addition, this study will contribute much needed data to the clinical trials community on the natural history of the motor function in CP over short-term (less than 1 year) time periods relevant to the conduct of clinical trials and assess the safety of AlloCB and hCT-MSC infusion in children with cerebral palsy.

What are the participation requirements?

Yes

Inclusion Criteria

1. Age ≥24 months and ≤60 months adjusted age at the time of enrollment.

2. Diagnosis: Unilateral or bilateral hypertonic cerebral palsy secondary to in utero or perinatal stroke/hemorrhage, hypoxic ischemic encephalopathy (including, but not limited to, birth asphyxia), and/or periventricular leukomalacia.

3. Performance status: Gross Motor Function Classification Score levels I - IV

4. Review of brain imaging (obtained as standard of care prior to study entry) does not suggest a genetic condition or brain malformation.

5. Legal authorized representative consent.

No

Exclusion Criteria

1. Available qualified autologous cord blood unit.

2. Hypotonic or ataxic cerebral palsy without spasticity.

3. Autism and autistic spectrum disorders.

4. Hypsarrhythmia.

5. Legally blind

6. Intractable seizures causing epileptic encephalopathy.

7. Evidence of a progressive neurologic disease.

8. Has an active, uncontrolled systemic infection or documentation of HIV+ status.

9. Known genetic disease or phenotypic evidence of a genetic disease on physical exam.

10. Concurrent genetic or acquired disease or comorbidity(ies) that could require a future allogeneic stem cell transplant.

11. Requires ventilatory support, including home ventilator, CPAP, BiPAP, or supplemental oxygen.

12. Impaired renal or liver function as determined by serum creatinine >1.5mg/dL and/or total bilirubin >1.3mg/dL except in patients with known Gilbert's disease.

13. Possible immunosuppression, defined as WBC <3,000 cells/mL or absolute lymphocyte count (ALC) <1500 with abnormal T-cell subsets.

14. Patient's medical condition does not permit safe travel.

15. Previously received any form of cellular therapy.

Locations

Location

Status