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ASC - Autism Study

NCT05602116 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-09-26

No results posted yet for this study

Summary

The ASC - Autism Pilot Study is a single center randomized open dose titrating phase I clinical intervention pilot trial with the aim of investigating safety and treatment effect of an allogeneic adipose tissue derived mesenchymal stromal cell product (C2C\_ASC) in children with autism spectrum disorder (ASD) and gastrointestinal symptoms.

Conditions

  • Autism Spectrum Disorder
  • Gastrointestinal Dysfunction
  • Leaky Gut Syndrome
  • Mesenchymal Stromal Cells
  • Inflammatory Bowel Diseases

Interventions

DRUG

Adipose tissue derived mesenchymal stromal/stem cells (Cell2Cure®)

The Investigational Product is a C2C\_ASC cell product (Cell2Cure®, Cell2Cure Aps, Denmark). C2C\_ASC is an advanced therapy investigational medicinal product (ATIMP) manufactured from abdominal adipose tissue derived mesenchymal stromal cells (ASC) from healthy donors. C2C\_ASC is aseptically procured and manufactured according to tissue law and GMP by Cell2Cure ApS or Cardiology Stem Cell Center, Rigshospitalet, Copenhagen, Denmark, using manual isolation of cells from abdominal fat tissue, xeno-free cell expansion in automated closed bioreactor systems and cryopreservation of the final product. The active substance is the in vitro expanded ASCs. The final product, C2C\_ASC, is provided as a cryopreserved suspension of 50 million ASCs per ml with a total volume of 1,3 ml per vial. The excipient is CryoStor10 (Biolife Solutions), holding 10% DMSO.

Sponsors & Collaborators

  • Cell to Cure ApS

    lead INDUSTRY

Principal Investigators

  • Jens Kastrup · Cell to Cure ApS

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-09
Primary Completion
2024-06-28
Completion
2024-09-20

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05602116 on ClinicalTrials.gov