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

NCT02208713 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-04-27

No results posted yet for this study

Summary

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.

Conditions

  • Dystrophy

Interventions

BIOLOGICAL

Intramuscular injection

Intramuscular injection of stem cells in patients with FSHD.

Sponsors & Collaborators

  • Royan Institute

    lead OTHER_GOV

Principal Investigators

  • Hamid Gourabi, PhD · Head of Royan Institute

  • Nasser Aghdami, MD,PhD · Head of Department of Regenerative Medicine & Cell therapy center of Royan Institute

  • Mahdi Vahid Dastjerdi, MD · Scientific Board of BouAli Hospital, Azad University

  • Leila Arab, MD · Department of Regenerative Medicine & cell therapy of Royan Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-11-30
Completion
2017-12-31

Countries

  • Iran

Study Locations

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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 NCT02208713 on ClinicalTrials.gov