跳至主要内容
临床试验/NCT06764719
NCT06764719招募中不适用

Characterization of Cryopreserved Plucked Hair Follicles and Generation of Functional Cell Lines for Disease Modeling and Cell Replacement Therapies

Acorn Biolabs Inc.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Characterize primary cellular outgrowth(s)

研究概览

简要总结

To explore the application of cells expanded from plucked hair follicles after collection, transport, and cryopreservation, in disease modeling and cell-based therapies.

详细描述

Hair Follicles collected and transported in Acorn's proprietary transport media can serve has therapeutic starting materials for future cell-based therapeutics. This study is to characterize primary cell outgrowth, functional stem cell generation and induced pluripotent stem cell line(s) from primary outgrowth(s) as well as evaluate and characterize differentiation of stem cell lines into functional cell types required for various disease states and cell-based application(s).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Gender: Male or Female.
  • Age: ≥18 and ≤80 years.
  • Language proficiency: Able to read and understand English.
  • Informed consent: Willing to provide written, informed consent to participate in all study activities.

排除标准

  • Scalp/Hair Disorders: Subjects diagnosed with active scalp infections or inflammatory skin conditions.
  • Systemic Conditions: Subjects with chronic illnesses, such as autoimmune diseases or diabetes, that may impact scalp health or wound healing.
  • Medications: Subjects on immunosuppressants, steroids, or other medications associated with hair loss.

结局指标

主要结局

Characterize primary cellular outgrowth(s)

时间窗: 30 days

10 hair follicles will be placed in a tissue culture plate per participants. Over the course of 30 days, the outgrowth percentage (the number of outgrowths present out of 10 will be monitored and the confluency (percent of cells present in relation to surface area) will be noted for each participant.

Evaluate functional stem cell generation and induced pluripotent stem cell line(s) from primary outgrowth(s)

时间窗: 21 days

1 million keratinocytes will be taken for reprogramming for each participant. The number of iPS colonies observed on day 21 will be noted, resulting in a reprogramming efficiency score.

Evaluate and characterize differentiation of stem cell lines into functional cell types required for various disease states and cell-based application(s)

时间窗: 30 days

iPS cell lines which have been confirmed to be pluripotent will be differentiated into pancreatic progenitor cells and hematopoietic stem cells. The cells will be analyzed using FLOW cytometry and the percentage of double positive cells will be noted for each participant. This will be repeated for multiple pathways such as the hematopoietic and endothelial lineage(s).

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验