---
title: Intramuscular Transplantation of Muscle Derived Stem Cell and Adipose Derived Mesenchymal Stem Cells in Patients With Facioscapulohumeral Dystrophy (FSHD)
nct_id: NCT02208713
overall_status: UNKNOWN
phase: PHASE1
sponsor: Royan Institute
study_type: INTERVENTIONAL
primary_condition: Dystrophy
countries: Iran
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02208713.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02208713"
ct_last_update_post_date: 2017-04-27
last_seen_at: "2026-05-12T06:08:11.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Intramuscular Transplantation of Muscle Derived Stem Cell and Adipose Derived Mesenchymal Stem Cells in Patients With Facioscapulohumeral Dystrophy (FSHD)

**Official Title:** Intramuscular Transplantation of Autologous Muscle Derived Stem Cell(MDSC) and Adipose Derived Mesenchymal Stem Cells (AD-MSC) in Patients With Facioscapulohumeral Dystrophy (FSHD), Phase I Clinical Trial

**NCT ID:** [NCT02208713](https://clinicaltrials.gov/study/NCT02208713)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 21
- **Lead Sponsor:** Royan Institute
- **Conditions:** Dystrophy
- **Start Date:** 2014-05
- **Completion Date:** 2017-12
- **CT.gov Last Update:** 2017-04-27

## Brief 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.

## Detailed Description

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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 50 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Stem cell recipient** (EXPERIMENTAL) — The patients with FSHD who underwent muscle derived stem cell and Adipose derived mesenchymal stem cell with intramuscular injection.

## Interventions

- **Intramuscular injection** (BIOLOGICAL) — Intramuscular injection of stem cells in patients with FSHD.

## Primary Outcomes

- **Myalsia** _(time frame: 1month)_ — Evaluation the presence of myalsia 1month after cell injection.
- **Mass formation** _(time frame: 6 months)_ — Evaluation the probability of mass formation 6 months after cell injection.

## Secondary Outcomes

- **Hematoma** _(time frame: 1 month)_
- **Muscle bulk** _(time frame: 6 months)_
- **CPK** _(time frame: 1month)_

## Locations (1)

- Royan Institute, Tehran, Iran — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.royan institute|tehran||iran` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02208713.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02208713*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*