国卫生与公众服务部部长呼吁加快干细胞疗法：这对再生健康意味着什么

本周给所有对再生医学感兴趣的人带来了一条重大新闻：美国卫生与公众服务部部长小罗伯特·f·肯尼迪（RFK Jr.）公开呼吁在美国加快干细胞治疗的合法化进程。

This week brought major news for anyone interested in regenerative medicine: Secretary of Health and Human Services Robert F. Kennedy Jr. (RFK Jr.) publicly called for the fast-tracking and broader legalization of stem cell therapies in the United States.

RFK Jr.的声明在再生健康社区内外引发了一波讨论。

RFK Jr.’s announcement has sparked a wave of discussion across the regenerative health community and beyond.

随着新一届政府的成立和雪佛龙案的推翻，多个行业开始放松管制，在新上任的卫生与公众服务部部长小罗伯特·肯尼迪（RFK Jr.）的监督下，对药品监管产生了一系列影响。

With the advent of a new administration and the overturning of Chevron comes deregulation initiatives across several industries, creating a slew of implications for drug regulation under the watch of the newly minted Secretary of the Department of Health and Human Services, Robert Kennedy, Jr. (RFK Jr.).

对干细胞产业放松管制可能会对制药市场和北卡罗莱纳州的研究三角产生广泛影响。

The possible deregulation of the stem cell industry could have extensive effects on the pharmaceutical market and North Carolina’s research triangle.

以干细胞工程为基础的再生医学在医学时代精神中日益突出，尤其是在2006年山中伸弥和高桥和敏共同撰写的一项研究发现，“有可能对多能成体干细胞进行重新编程，使其达到多能状态”。

Regenerative medicine rooted in stem cell engineering has become increasingly prominent in the medical zeitgeist, especially since a 2006 study authored by Shinya Yamanaka and Kazutoshi Takahashi discovered that it was “possible to reprogram multipotent adult stem cells to their pluripotent state.

然而，开发再生药物有其风险，需要监管以防止危险产品进入市场和患者体内。

Nevertheless, developing regenerative medicines has its perils and warrants regulation to combat dangerous products reaching the market and patients’ bodies.

因此，根据其在公共卫生服务法（PHSA）下监管再生药物治疗的权力，FDA根据21 C.F.R.§1271发布了监管结构，以监管人类细胞，组织或细胞或组织产品（HCT/Ps）（指含有或由人类细胞或组织组成的物品），用于植入，移植，输注或转移到人类受体中。

As a result and pursuant to its authority to regulate regenerative medicinal therapies under the Public Health Service Act (PHSA),[8] the FDA has issued a regulatory structure under 21 C.F.R. § 1271 to regulate human cells, tissues, or cellular or tissue-based products (HCT/Ps) mean[ing] articles containing or consisting of humans cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.

由于HCT/Ps的广泛性质，FDA以“分层，基于风险”的形式对产品进行监管，其中某些HCT/Ps接受更高的监管审查

Due to the broad nature of HCT/Ps, the FDA regulates the products in a “tiered, risk-based” format, where certain HCT/Ps receive higher regulatory scrutiny.

HCT/Ps默认被归类为“药物”，因此，受FDA的整个监管计划的约束

HCT/Ps are classified as “drugs” by default and are, therefore, subject to the entirety of the FDA’s regulatory scheme

干细胞疗法的使用在未来十年势必会受到越来越多的诉讼，而现任政府对干细胞治疗的看法可能会改变这一诉讼的进程。

Nevertheless, the use of stem cell therapies is bound to be subject to increasing litigation over the next decade, and the current administration’s views on stem cell treatments may alter this course of litigation.

2024年10月，RFK Jr.公开批评FDA通过“积极抑制……干细胞”“向公众健康宣战”

In October 2024, RFK Jr. publicly criticized the FDA’s “war on public health” through its “aggressive suppression of … stem cells.”