Clonal Fetal Mesenchymal Stem Cells (cfMSCs) for the Control of Immune-related Disorders

Tissue Damage Clinical Trial

Official title:

Clonal Fetal Mesenchymal Stem Cells (cfMSCs) for the Control of Immune-related Disorders

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03123458
• Other study ID #: GIMI-IRB-17001
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: March 13, 2017
• Last updated: February 23, 2018
• Start date: January 1, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2018
• Source: Shenzhen Geno-Immune Medical Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

MSCs have been extensively studied and clinically evaluated for the treatment of autoimmune diseases and graft versus host disease (GVHD) after hematopoietic stem cell transplantation (HSCT). The variable source of MSCs and the lack of consistency of primary tissue-derived MSCs are major obstacles to reliable translational applications of such therapeutic cell products. Fetal tissue-derived clonal MSCs (cfMSCs) have extended expansion potential and express rich levels of various growth factors, and thus can achieve quality consistency. Careful evaluation of fMSCs in clinical studies has not been conducted. Autoimmune diseases involve aberrant immune responses that harm tissues and organs. GVHD is a serious and often fatal problem associated with HSCT. MSCs have immunomodulatory and immunosuppressive effects. In many studies, MSCs have demonstrated promising beneficial effects that reduce severe autoimmune reactions, diminish symptoms of chronic GvHD and therapy-resistant acute GvHD including steroid-resistant GVHD. The safety and therapeutic effects of phenotype and functionally characterized fMSCs still require extensive clinical evaluation. This study aims to assess the safety and the potential beneficial effects of infusion of various dosages of third party fMSCs for the control of severe symptoms associated with acute and chronic immune-related disorders.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 80 Years

Eligibility

Inclusion Criteria:

1. Informed consent.

2. No available alternative treatment that can reduce the symptoms

3. Patients are required to meet the following inclusion criteria:

• 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.

Exclusion Criteria:

1. Inability to give informed consent.

2. Patients with ongoing infection or history of cancer.

3. Patients with poor clinical conditions with the life expectancy of less than 14 days.

4. Pregnancy.

Related Conditions & MeSH terms

• Disease
• Immune Related Disorder
• Tissue Damage

Intervention

Biological:
• clonal fetal MSCs

Locations

Country	Name	City	State
China	Aerospace Center Hospital	Beijing
China	Capital Institute of Pediatrics affiliated Children's hospital	Beijing	Beijing
China	Shenzhen Geno-immune Medical Institute	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Geno-Immune Medical Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with reduced symptoms or stabilized conditions after treatment	Short term clinical effects measured by physiological and serological parameters related to the disease condition and symptoms using prepared study assessment table.	after 1 month from fMSC infusion