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A phase I clinical trial for umbilical cord mesenchymal stem cells in the treatment of refractory systemic sclerosis

A phase I clinical trial for umbilical cord mesenchymal stem cells in the treatment of refractory systemic sclerosis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020171
Enrollment
Unknown
Registered
2018-12-19
Start date
2019-04-01
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic sclerosis

Interventions

The first stage: Stem cell low dose group:intravenous inject MSCs
The first stage: Stem cell middle dose group:intravenous inject MSCs
The first stage: Stem cell high dose group:intravenous inject MSCs
The second stage: Stem cell optimal dose group:intravenous inject MSCs
The second stage: conventional therapy:oral conventional drugs

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The diagnosis are in accordance with the classification criteria of systemic sclerosis revised by ACR/EULAR in 2013; 2. Combine refractory acromegaly ulcer; 3. Patients aged 18-70 years; 4. Haven't received the therapy of blood products in the past 50 days; 5. Patients agree to sign the agreement paper; 6. ECOG score 0-4 points.

Exclusion criteria

Exclusion criteria: 1. Have a history of severe allergic reactionshighly;allergic constitution; 2. Severe infections,or combine malignancies; 3. End-stage cardiac ,renal insufficiency; 4. Insanity,severe cognitive impairment; 5. Being infected by human immunodeficiency virus (HIV), syphilis, hepatitis or other diseases; 6. Coagulation disorders; 7. Pregnant and breeding women.

Design outcomes

Primary

MeasureTime frame
skin thickness, elasticity, temperature;immune indices;pulmonary function;ulcer area and healing time;NVC;inflammation;

Countries

China

Contacts

Public ContactYi Liu

West China Hospital, Sichuan University

yi2006liu@163.com+86 18980602061

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026