NCT04385056

Evaluate Umbilical Cord-derived Allogeneic Mesenchymal Stem Cells for the Treatment of Bradykinesia

An Open-label, Dose-escalation Study to Evaluate the Use of Umbilical Cord-derived Allogeneic Mesenchymal Stem Cells (UC-MSCs) for the Treatment of Bradykinesia

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: IMAC Holdings, Inc. · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

Investigate the safety and tolerability of umbilical cord-derived allogeneic mesenchymal stem cells to treat patients with Bradykinesia.

Detailed description

While the pathophysiological changes that result in the symptoms of bradykinesia are poorly understood, an inflammatory component appears to be involved. Human umbilical cord-derived allogeneic mesenchymal stem cells have documented anti-inflammatory properties, which suggest these cells may be effective at treating Bradykinesia. It is understood that perinatal products are potent immune modulators. It is believed that the positive symptomatic effects are secondary to the modulation of the immune system, and specifically the reduction in pathological inflammation. The study is designed to evaluate the safety and tolerability of umbilical cord-derived allogeneic mesenchymal stem cells to treat patients with Bradykinesia.

Conditions

• Bradykinesia

Interventions

Type	Name	Description
BIOLOGICAL	MSCTC-0010	MSCTC-0010 is a suspension product for infusion. The active ingredient is the umbilical cord-derived allogeneic mesenchymal stem cells (US-MSCs).

Timeline

• Start date: 2020-12-15
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2020-05-12
• Last updated: 2021-01-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study