MedDataX Logo

Intramuscular Transplantation of Muscle Derived Stem Cell and Adipose Derived Mesenchymal Stem Cells in Patients With Facioscapulohumeral Dystrophy (FSHD)

NCT ID: NCT02208713

Last Updated: 2017-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Facioscapulohumeral Dystrophy is a Autosomal dominant inherited dystrophy with the prevalence of 1:20,000 and it is the third most common dystrophy after the dystrophinopathies and myotonic dystrophy. The symptoms including: Pain, facial weakness, scapular fixator, humeral, truncal, pelvic girdle and lower-extremity weakness, High frequency hearing loss, Retinal telangiectasia . The existing treatments are not effective so, cell therapy is a new hope to improve patients' quality of life. Therefore, We design this clinical trial to evaluate the safety and feasibility of stem cell transplantation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase 2 Open-label Extension Study of AOC 1020 in Participants with Facioscapulohumeral Muscular Dystrophy (FSHD)

NCT06547216

FSHD FSHD1 FSHD2 +24 more
ENROLLING_BY_INVITATION PHASE2

Phase 1/2 Study of AOC 1020 in Participants With Facioscapulohumeral Muscular Dystrophy (FSHD)

NCT05747924

FSHD FSHD1 FSHD2 +24 more
ACTIVE_NOT_RECRUITING PHASE1/PHASE2

Unraveling Metabolic Involvement in Facioscapulohumeral Dystrophy Through Metabolomics

NCT06086548

Facioscapulohumeral Muscular Dystrophy
NOT_YET_RECRUITING

A Study to Evaluate RO7204239 in Participants With Facioscapulohumeral Muscular Dystrophy

NCT05548556

Facioscapulohumeral Muscular Dystrophy (FSHD)
ACTIVE_NOT_RECRUITING PHASE2

Safety and Preliminary Efficacy of ULSC in Facioscapulohumeral Muscular Dystrophy (FSHD)

NCT07086521

FSHD - Facioscapulohumeral Muscular Dystrophy
RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this study, we select 15 patients with FSHD based on eligibility criteria. All the patients underwent physical examination, laboratory evaluations, EMG-NCV, muscle sonography and muscle MRI. Then, a sample of patient's muscle is taken from Biceps Femoralis to isolate and culture of MDSC. The AD-MSC is prepared from Royan Adipose Tissue Bank. The patient is admitted in general hospital, and the cell suspensions are injected into biceps, triceps and trapezoids muscles by neurologists. After transplantation, the patients will be under observation for 5 hours and will be discharged if no side effect happen. All the patients will be followed at 1,2,4,6 and 12 months after cell injection.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dystrophy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stem cell recipient

The patients with FSHD who underwent muscle derived stem cell and Adipose derived mesenchymal stem cell with intramuscular injection.

Group Type EXPERIMENTAL

Intramuscular injection

Intervention Type BIOLOGICAL

Intramuscular injection of stem cells in patients with FSHD.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intramuscular injection

Intramuscular injection of stem cells in patients with FSHD.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Intramuscular cell transplantation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age: 18-50
2. Both gender
3. Weakness of face muscle
4. FSHD phenotype positive
5. Genetic Test confirmation for FSHD

Exclusion Criteria

1. Co - morbidities: Heart \& respiratory diseases,malignancy, rheumatologic disorders
2. Progressive form of disease
3. Not able to sign the consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Royan Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

Nasser Aghdami, MD,PhD

Role: STUDY_DIRECTOR

Head of Department of Regenerative Medicine & Cell therapy center of Royan Institute

Mahdi Vahid Dastjerdi, MD

Role: STUDY_DIRECTOR

Scientific Board of BouAli Hospital, Azad University

Leila Arab, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Regenerative Medicine & cell therapy of Royan Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royan Institute

Tehran, , Iran

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Iran

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nasser Aghdami, MD,PhD

Role: CONTACT

[email protected]
(+98)23562000 ext. 516

Leila Arab, MD

Role: CONTACT

[email protected]
(+98)23562000 ext. 414

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nasser Aghdami, MD,PhD

Role: primary

[email protected]
(+98)212356000 ext. 516

Leila Arab, MD

Role: backup

[email protected]
(+98)23562000 ext. 414

Related Links

Access external resources that provide additional context or updates about the study.

http://Royaninstitute.org

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Royan-Nerve-007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Myotonic Dystrophy and Facioscapulohumeral Muscular Dystrophy Registry
NCT00082108 RECRUITING
Clinical Trial Readiness to Solve Barriers to Drug Development in FSHD
NCT03458832 RECRUITING
Walking ANalysis Interest in Persons wiTh facioscapulohumEral Muscular Dystrophies
NCT06600308 RECRUITING NA
Study of ACE-083 in Patients With Facioscapulohumeral Muscular Dystrophy (FSHD)
NCT02927080 TERMINATED PHASE2
Randomized Double-Blind Placebo-Controlled Adaptive Design Trial Of Intrathecally Administered Autologous Mesenchymal Stem Cells In Multiple System Atrophy
NCT05167721 ACTIVE_NOT_RECRUITING PHASE2
Dietary Protein Requirements in Adults With Facioscapulohumeral Muscular Dystrophy
NCT06785428 RECRUITING NA
A Study to Evaluate Del-brax (Also Referred to as AOC 1020) in Participants With FSHD
NCT07038200 RECRUITING PHASE3
Effects of NMES on Muscle Function of Patients With FSHD: a Double-blind Randomized Controled Clinical Trial
NCT02861911 TERMINATED NA
The Effect of Human Adipose Tissue-derived MSCs in Romberg's Disease
NCT01309061 COMPLETED NA
Mesenchymal Stem Cell Therapy in Multiple System Atrophy
NCT02315027 ACTIVE_NOT_RECRUITING PHASE1/PHASE2
Intraventricular Transplantation of Mesenchymal Stem Cell in Patients With ALS
NCT01759784 WITHDRAWN PHASE1
Clinical Trial Readiness Network FSHD France: Prospective 24 Months MRI Study
NCT04038138 ACTIVE_NOT_RECRUITING NA
Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALS
NCT01759797 COMPLETED PHASE1
Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease
NCT00004771 COMPLETED PHASE2
Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (ALS)
NCT03268603 ACTIVE_NOT_RECRUITING PHASE2
Study of ARO-DUX4 in Adult and Adolescent Patients With Facioscapulohumeral Muscular Dystrophy Type 1
NCT06131983 RECRUITING PHASE1/PHASE2
Muscle Stem Cell Quality in Atrophy
NCT06077734 NOT_YET_RECRUITING
Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy (FSHD)
NCT00027391 COMPLETED NA
Effects Antioxidants Supplementation on Muscular Function Patients Facioscapulohumeral Dystrophy (FSHD)
NCT01596803 COMPLETED NA
Evaluate Safety and Biological Activity of ATYR1940 in Participants With Limb Girdle Muscular Dystrophy 2B (LGMD2B) and Facioscapulohumeral Muscular Dystrophy (FSHD)
NCT02579239 COMPLETED PHASE1/PHASE2
Pro-inflammatory Cytokines in Facioscapulohumeral Muscular Dystrophy (CYTOKINE-FSH)
NCT04694456 COMPLETED NA
Safety, Tolerability, Pharmacokinetics, and Biological Activity of ATYR1940 in Adult Participants With Muscular Dystrophy
NCT02239224 COMPLETED PHASE1/PHASE2
Study to Evaluate the Long-Term Safety, Tolerability, and Biological Activity of ATYR1940 in Participants With Limb Girdle and Facioscapulohumeral Muscular Dystrophy (FSHD)
NCT02836418 COMPLETED PHASE1/PHASE2
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Of AJ201 In Patients
NCT05517603 COMPLETED PHASE1/PHASE2
Digital Biotyping of FSHD Patients and Controls
NCT04999735 COMPLETED