When Muse cells are used in a cell product, the cell product may also comprise dimethyl sulfoxide (DMSO), serum albumin and the like for protection of the cells, and any antibiotic and the like for prevention of contamination and proliferation of bacteria. The cell product may further comprise other pharmaceutically acceptable components (e.g., carriers, excipients, disintegrants, buffer agents, emulsifiers, suspending agents, soothing agents, stabilizers, preservatives, antiseptics, physiological saline). These agents and drugs can be added to the cell product at appropriate concentrations by the skilled person. Thus, Muse cells can also be used in a pharmaceutical composition comprising various additives.

The number of Muse cells contained in the cell product prepared above can be appropriately adjusted to achieve desired effects on treatment of hair damage, in consideration of, for example, the sex, age, and weight of the subject, the condition of the affected area, and the condition of such cells to be used. Individuals as the subject include, but not limited to, mammals such as human. The Muse cell-containing cell product of the present disclosure may be administered in multiple times at appropriate intervals (e.g., twice a day, once a day, twice a week, once a week, once every two weeks, once a month, once every two months, once every three months, or once every six months) until the desired therapeutic effect is obtained. Therefore, the therapeutically effective amount is preferably, for example, 1 to 10 doses of 1×10³to 1×10¹⁰cells/individual/dose for a year, depending on the state of the subject. The total amount administered to an individual is, without limitation, 1×10³cells to 1×10¹⁰cells, preferably 1×10⁴cells to 1×10¹⁰cells, more preferably 1×10⁵cells to 1×10⁹cells.

Muse cells to be used in the cell product of the present disclosure are characterized in that these migrate and engraft to a disorder site. Thus, the site and method of administration of the cell product in administration of the cell product are not limited, and examples include intravascular administration (intravenous, intra-arterial), and topical administration. Preferred is intravascular administration (intravenous, intra-arterial), or topical administration to a hair damage site.

The Muse cell-containing cell product of the present disclosure allows for realization of clinical treatment of hair damage, namely, gray hair, hair loss, thinning hair, and/or the like, in particular, gray hair.

The present disclosure will be described in more detail with reference to examples below, but is not limited to the examples in any way.

EXAMPLES
<Preparation of Human Muse Cells>

Muse cells were obtained according to the method for isolation and identification of human Muse cells described in WO2011/007900. Such Muse cells were subjected to expansive enrichment culture with culture of mesenchymal stem cells under stress conditions.

A clinical trial for patients with cerebral infarction was performed under the following conditions.

- Name of disease: cerebral infarction
- Overview of trial: to examine safety and effectiveness in intravenous administration of CL2020, for patients with cerebral infarction, with placebo as control.
- Design of trial: placebo-control, randomization (assigned at a ratio of positive control 2.5:placebo 1), double-blind
- Number of cases: 35 cases (positive control 25 cases, placebo 10 cases)
- Age: 20 years old or older and younger than 80 years old
- Gender: both
- Eligibility criteria:
  - Patient with cerebral infarction, having nervous symptoms such as physical dysfunction at the time point after lapse of the period of application of standard acute-phase treatment
  - Patient within 14 days to 28 days after the onset of cerebral infarction
  - Patient with a National Institutes of Health Stroke Scale (NIHSS) of 6 or greater upon registration, and the like
- Exclusion criteria:
  - Patient with a decreased level of consciousness observed
  - Patient with hemorrhagic transformation observed by CT or MRI, and the like
- Administration method: drip infusion of one bag of CL2020 (Muse cells: 1.5×10⁷cells/about 52 ml) or placebo (about 52 ml) over 10 to 15 minutes.
- Test period: 52 weeks
- Observation/inspection items:
  - 12-Lead electrocardiogram
  - Blood test, urine test
  - Assessment of symptoms of cerebral infarction (NIHSS (National Institute of Health Stroke Score), mRS (modified Rankin Scale), SIAS (Stroke Impairment Assessment Set), BI (Barthel Index), FMMS (Fugl-Meyer Motor Scale), EQ-5D-5L (EuroQol-5-dimension 5 level))
  - Others

- Results of primary endpoint:

No severe adverse effect causing problems in the conduct of the clinical trial was observed with respect to the safety until 52 weeks after administration of CL2020, as the primary endpoint, and favorable tolerability could be confirmed.

- Results of secondary endpoint (summary):
  - Most patients had a modified Rankin Scale (mRS) of 4 or 5 before administration of placebo (bogus medicine) or CL2020.
  - The lower limit of 95% confidence interval (21.1 to 61.3%) of the rate (responder rate) of a subject having a mRS of 2 or less after 12 weeks (3 months) from administration exceeded a threshold responder rate of 8.7% set in advance, and the treatment effect of CL2020 was confirmed. The responder rate at 12 weeks after administration reached 40% (10 cases/25 cases) in the CL2020-administration group, and exceeded by 30% as compared with 10% (1 case/10 cases) in the placebo-administration group (p=0.08). The responder rate at 52 weeks (one year) after administration reached 68.2% (15 cases/22 cases) in the CL2020-administration group, and a between-group difference of 30% or more, from that in the placebo-administration group (37.5%, 3 cases/8 cases), was kept.