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Cord Tissue Mesenchymal Stromal Cells · 1 trial · 2 indications
The primary outcome measure is the mean of the Socialization and Communication Subscale Standard Scores on the Vineland Adaptive Behavior Scales (VABS-3) from the Comprehensive Interview form. The primary endpoint is the change in this outcome measure from baseline to six months before the second infusion. A positive change in the scores indicates an improvement in socialization and communication. A standard score of 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Domain scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers.
| Arm | Type | Description |
|---|---|---|
| MSC | EXPERIMENTAL | One dose of 6x10e6 cells/kg administered intravenously. |
| Placebo Infusion | PLACEBO_COMPARATOR | Placebo infusion |
| Name | Type | Description |
|---|---|---|
| Cord Tissue Mesenchymal Stromal Cells | BIOLOGICAL | Human Umbilical Cord Tissue Derived Mesenchymal Stromal Cells (hCT-MSC), isolated and expanded from umbilical cord tissue from allogeneic unrelated donors. One dose of 6x10e6 cells/kg administered intravenously. |
| Placebo Infusion | OTHER | Placebo comparative infusion |
Inclusion Criteria 1. Age ≥ 4 years to \< 12 years (11 years, 364 days) at the time of consent 2. Confirmed clinical DSM-5 diagnosis of Autism Spectrum Disorder using the DSM-5 Checklist as informed by the Brief Observation of Symptoms of Autism (BOSA) and the Autism Diagnostic Interview-Revised (A...
Cord Tissue Mesenchymal Stromal Cells is an investigational cell therapy being studied for the treatment of autism spectrum disorder. It is currently in Phase 2 clinical development and has not been approved by the FDA. The therapy is being evaluated in children with autism to assess its safety and efficacy.
Cord Tissue Mesenchymal Stromal Cells is being developed by Cryo-Cell International Inc., a company traded on the stock exchange under the ticker symbol CCEL. The company is conducting clinical research to evaluate this investigational therapy for autism spectrum disorder.
Cord Tissue Mesenchymal Stromal Cells is in Phase 2 clinical development. It is an investigational therapy and has not received FDA approval. The Phase 2 trial has been completed, and the therapy is being studied for the treatment of autism spectrum disorder in children.
Cord Tissue Mesenchymal Stromal Cells has one completed clinical trial registered as NCT04089579, titled 'hCT-MSC in Children With Autism Spectrum Disorder.' This Phase 2 study enrolled 137 participants in the United States and was a randomized, double-blind, placebo-controlled trial involving children aged 4 years and older.
Yes, Cord Tissue Mesenchymal Stromal Cells is also referred to as hCT-MSC, which stands for human Cord Tissue Mesenchymal Stromal Cells. The clinical trial NCT04089579 uses the hCT-MSC designation in its title, and both names refer to the same investigational therapy being developed for autism spectrum disorder.