NCT03123458

Brief Summary

The primary objectives are to evaluate the safety and efficacy of infusion of the third party fully-characterized clonally derived fetal MSCs (cfMSCs) for the control of severe symptoms associated with acute and chronic immune-related disorders and tissue damage.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
45mo left

Started Jan 2025

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Jan 2025Dec 2029

First Submitted

Initial submission to the registry

March 13, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
7.7 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

4 years

First QC Date

March 13, 2017

Last Update Submit

September 4, 2025

Conditions

Immune Related DisorderTissue Damage

Keywords

MSCGVHDstransplantation

Outcome Measures

Primary Outcomes (1)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Safety of cfMSC infusion acute and prolonged

    up to one month

Secondary Outcomes (1)

  • Number of participants with reduced symptoms or stabilized conditions after treatment

    after 1 month from fMSC infusion

Study Arms (1)

Single arm, cfMSC to treat immune disorders

EXPERIMENTAL

cfMSCs treatment

Biological: clonal fetal MSCs

Interventions

clonal fetal MSCsBIOLOGICAL

clonal fetal MSCs

Single arm, cfMSC to treat immune disorders

Eligibility Criteria

Age1 Year - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent.
  • No available alternative treatment that can reduce the symptoms
  • Any patient that has clinically documented abnormal immune or age-related disorders including acute and chronic GVHD. Patients may receive best available treatment for the control of disease symptoms.
  • Patients with symptoms associated with genetic defects or infectious diseases are not eligible.

You may not qualify if:

  • Inability to give informed consent.
  • Patients with ongoing infection or history of cancer.
  • Patients with poor clinical conditions with the life expectancy of less than 14 days.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Capital Institute of Pediatrics affiliated Children's hospital

Beijing, Beijing Municipality, 100020, China

Location

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

Location

Aerospace Center Hospital

Beijing, 100049, China

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

March 13, 2017

First Posted

April 21, 2017

Study Start

January 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

September 8, 2025

Record last verified: 2025-09

Locations

CN(3)