Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
Top 3 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 3 | PHASE3 | Xanomeline and trospium chloride, KarX-EC |
| Definium Therapeutics, Inc. | DFTX | 1 | PHASE2 | DT402 |
| MapLight Therapeutics, Inc. | MPLT | 1 | PHASE2 | ML-004 |
Cord Tissue Mesenchymal Stromal Cells is being studied for the treatment of autism and autism spectrum disorder. It is an investigational cell-based therapy being developed by Cryo-Cell International Inc. The research focuses on children with autism spectrum disorder, with a completed Phase 2 trial evaluating its use in this population.
Cord Tissue Mesenchymal Stromal Cells is being developed by Cryo-Cell International Inc., which trades under the ticker symbol CCEL. The company is advancing this cell therapy as a potential treatment for autism spectrum disorder.
Cord Tissue Mesenchymal Stromal Cells is in Phase 2 clinical development. A Phase 2 trial has been completed, and the therapy remains investigational. It has not been approved by the FDA for any indication.
One clinical trial has evaluated Cord Tissue Mesenchymal Stromal Cells: NCT04089579, titled hCT-MSC in Children With Autism Spectrum Disorder. This completed Phase 2 trial enrolled 137 participants in the United States. It was randomized, double-blind, and placebo-controlled, and included children aged 4 years and older.
No, Cord Tissue Mesenchymal Stromal Cells is not approved by the FDA. It is an investigational therapy that has completed a Phase 2 clinical trial for autism spectrum disorder. Further clinical development would be required before any potential regulatory approval.